Systems and methods of mitigating negative effects of therapies with transcutaneous vibration

ABSTRACT

Systems and methods to mitigate negative effects of a drug in a treatment of a mental health condition include administering a drug to a subject in a therapy session; determining effects of the drug, the effects being counterproductive to the therapy session; and providing tactile stimulation to a subject with a stimulation device that generates transcutaneous vibratory output to be applied to a portion of a body of the subject during the therapy session, wherein the transcutaneous vibratory output is selected to reduce the counterproductive effects of the drug.

CLAIM TO PRIORITY

This application claims the benefit of the following provisionalapplications, which are hereby incorporated by reference in theirentirety: U.S. Ser. No. 62/788,564, filed Jan. 4, 2019, U.S. Ser. No.62/788,605, filed Jan. 4, 2019, and U.S. Ser. No. 62/867,591, filed Jun.27, 2019.

BACKGROUND Field

This disclosure provides systems and methods of facilitating neural oremotional state transitions.

Description of the Related Art

The autonomic nervous system (ANS) is a part of the peripheral andcentral nervous system and comprises the nerves that communicate betweenthe brain stem and the body's internal organs. The ANS comprises thecomplementary sympathetic and parasympathetic branches or systems. Thesympathetic nervous system is often referred to as a body's “fight orflight” system, as it prepares the body for intense physical activity toenhance the likelihood of survival when coping with threateningsituations. The parasympathetic nervous system—sometimes called the“rest and digest” system—does the opposite, as it causes the body torelax, and it can reduce or inhibit many of the body's high energyfunctions that are required for effectively managing survivalsituations.

The ANS functions below one's level of awareness through complexinteractions between its two branches to respond quickly andcontinuously to perturbations that threaten the stability of the body'sinternal environment. As such, the sympathetic and parasympatheticsystems work together to maintain homeostasis. Activity in the ANS maybe modulated intentionally by activities such as meditation and deepbreathing that improve parasympathetic activity.

The autonomic nervous system can be manipulated via sensory pathways.For example, in a resonance method periodic sensory stimulation mayevoke a physiological response that peaks at certain stimulusfrequencies. This includes a resonance mechanism that is characterizedby the peaking of the physiological response versus frequency such thatthe periodic sensory signals evoke an excitation of oscillatory modes incertain neural circuits. The most common example of this phenomenon ismusic. Music resonates with each person slightly differently, butnonetheless in a highly similar manner, that has the capacity toreliably induce significant shifts in awareness, cognition, mood, and ahost of other sensations. Fast loud music typically induces asympathetic physiological and subjective response, while slow gentlequiet music tends to elicit the opposite parasympathetic response. Thisgeneral rule with respect to intensity and frequency relationships tophysiological and subjective responses are similar for tactile and mostother stimuli.

Responses to sympathetic and parasympathetic stimulation are frequentlyantagonistic. For example, they have opposing or antagonistic effects onheart rate. While stimulation of the sympathetic branch increases heartrate, stimulation of the parasympathetic branch decreases heart rate. Inaddition, the body's response to activity in one branch depends on thelevel of activity in the other branch. Sympathetic and parasympatheticactivity make up a complex, dynamic system that is continuouslyadjusting to changing conditions in the body and in the externalenvironment. The ANS strives to optimize activity in each branch and tobalance the two branches in real time, depending on both internal andexternal conditions, thereby maintaining homeostasis.

In certain diseases and conditions, the balance between sympathetic andparasympathetic system activity is implicated either causally or inattempted remediation.

Accordingly, ways for affecting a subject's health or condition bystimulating and refining the function of the sympathetic and/orparasympathetic branches of the ANS, both acutely and progressively overtime, are desired. The present disclosure relates generally to a methodand apparatus for affecting a subject's health or condition by usinginformation regarding the sympathetic and/or parasympathetic branch ofthe autonomic nervous system to modulate and/or apply stimuli to thepatient (e.g., as a function of the heart rate) that stimulates thesympathetic and/or parasympathetic branch.

SUMMARY

Throughout this disclosure, methods and systems herein are directed atassisting a subject to reach a target state (e.g. calm, focus, flow,presence of being, asleep, wakeful, relaxed, aroused, euphoric, or aperformance state), maintain the target state, and/or prime the user tobe able to achieve the target state. The subject may provide input aboutthe desired target state to a processor associated with a transducer,and a transcutaneous vibratory output may be generated by the transducerto be applied to a portion of the subject's body. Throughout thisdisclosure, the transcutaneous vibratory output may be described ashaving variable parameters comprising a perceived pitch, a perceivedbeat, and a perceived intensity. Throughout this disclosure, a pluralityof perceived pitches and/or a plurality of perceived beats may be usedto generate the transcutaneous vibratory output. Throughout thisdisclosure, the transcutaneous vibratory output may be generated bymultiplicatively combining a sine wave-shaped envelope with a wavepattern having a perceived pitch, such as in accordance with theequation:[sin(2.0*π*freq_perceived_pitch*t)]*[sin(π*freq_perceived_beat*t)].Throughout this disclosure, a user's sensory thresholds, both lower andupper, may be used as bounds for the transcutaneous vibratory outputthat is generated. The sensory threshold may be determined via acalibration procedure, active data collection via survey questions, orpassive data collection via monitoring mobile device and applicationusage. The variable parameters can be modified based on the target statedesired, such as through a user interface of a device or automatically,and further to avoid habituation. The desired target state may beinferred based on the present condition of the subject, eitherdetermined manually and actively by user input or passively throughusers' mobile and environmental data and biometric or physiologicalsensing. Throughout this disclosure, physiologically sensed data mayinclude any of: heart rate (HR), heart rate variability (HRV), galvanicskin response (GSR), movement, respiration rate, temperature, SpO₂,spirometry, EEG, ECG, EMG, CO₂, motion, blood pressure, or glucose.Achieving the target state may include generating a secondtranscutaneous vibratory output, such as if the first is ineffective, ora transcutaneous vibratory output with multiple segments. As with any ofthe embodiments herein, the processor of the transducer may be incommunication with one or more sensors, with other systems, devices, ortransducers and any processor thereof, or with a remote server.

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state with their feedback as aid. The desired targetstate of the user is determined and a transcutaneous vibratory output isgenerated, which is designed or programmed to facilitate achieving thetarget state, maintaining the target state, or priming the user to beable to achieve the target state. The transcutaneous vibratory output isapplied to a portion of the subject's body (such as with a transducer)and user input on state achievement is obtained as feedback to thesystem. Failure to reach the target state may result in a secondtranscutaneous vibratory output being generated for application. In anyof the embodiments of this disclosure, a user interface of a devicecomprising a transducer, or a second device in communication with thetransducer, or an application executing on a mobile device incommunication with the transducer may be used to select the target stateand/or provide user feedback. A processor may be in electroniccommunication with the transducer and a user input device, wherein theprocessor causes the transducer to generate transcutaneous vibratoryoutputs when it receives input or instructions from the user inputdevice.

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state with sensor-based measurements or third partydata sources as feedback. Sensor-based measurements may include, but arenot limited to, heart rate, heart rate variability, respiration rate,and galvanic skin response. Third party data sources may include, butare not limited to, a health informatics application, an electronichealth record, a hospital data system, content of social media posts,metadata from use of a mobile device (smartphone), or content ofcommunications. The desired target state of the user is determined and atranscutaneous vibratory output is generated which is designed orprogrammed to facilitate achieving the target state, maintaining thetarget state, or priming the user to be able to achieve the targetstate. The transcutaneous vibratory output is applied to a portion ofthe subject's body (such as with a transducer) and sensor-basedmeasurements or third party data on state achievement is obtained asfeedback to the system. Failure to reach the target state may result ina second transcutaneous vibratory output being generated forapplication. Reaching the target state may cause discontinuation of thestimulation, or generation of a maintenance stimulation protocol. A userinterface of a device comprising a transducer, or a second device incommunication with the transducer, or an application executing on amobile device in communication with the transducer may be used to selectthe target state and provide user feedback. A processor may be inelectronic communication with the transducer, a physiological sensor,and, optionally, a user input device, wherein the processor causes thetransducer to generate transcutaneous vibratory outputs when it receivesinput or instructions from the user input device, sensor, or third partydata source, and generate further transcutaneous vibratory outputs inresponse to a determination of goal achievement based on the sensor orthird party data source.

Methods and systems disclosed herein are directed at calibrating amethod and/or system of assisting a subject to reach a target state. Amethod of calibration may involve selecting a first transcutaneousvibratory output based on the determined target state of the user,applying the vibratory output and measuring its effectiveness, such aswith sensors or user feedback. A second transcutaneous vibratory outputis then used to reach the same target state and its effectiveness issimilarly measured. A processor calibrates the method for achieving thetarget state based on the effectiveness determinations, choosing one ofthe vibratory outputs for subsequent attempts at achieving the targetstate, or generating a third transcutaneous vibratory output. Thecalibration method may alternatively utilize a plurality oftranscutaneous vibratory outputs in a corresponding session whoseeffectiveness is determined. Once an effective transcutaneous vibratoryoutput is identified, it is stored in a database. The database for othereffective transcutaneous vibratory outputs and selecting one of saidother effective transcutaneous vibratory outputs to be emitted with theelectronic transducer.

Another method of calibration commences as soon as the user begins useof the stimulation device. For a period of time, this calibrationinvolves determining a baseline, non-stressed state of a user byperiodically measuring a physiological parameter (e.g. heart rate (HR),heart rate variability (HRV), galvanic skin response (GSR), movement,respiration rate, temperature, SpO₂, spirometry, EEG, ECG, EMG, heartrate, CO₂, motion, blood pressure, or glucose) using a sensor combinedwith routine assessments of mobile device user and metadata. Then, whenthere is a deviation from baseline identified by a processor of a devicein communication with the sensor, a transcutaneous vibratory output isidentified in response and communicated to the processor for generationand application by the transducer. The user may assist in identifyingthe baseline state during the calibration period by inputtinginformation regarding their mood. The processor may also use contextualdata periodically received from a mobile device to determine thebaseline state, deviations therefrom, or mood. The contextual data,which may be used in any of the disclosed embodiments, may derive fromcontent of social media, a navigation application, a calendarapplication, a movement tracker, an amount of usage of the mobiledevice, keystrokes input into the mobile device, or a project managementapplication. As with all embodiments herein, if the transcutaneousvibratory output is not effective to assist the user to enter a targetstate, it may be modified (e.g. such as by varying one or more of thevariable parameters), discontinued, or a second transcutaneous vibratoryoutput may be generated and commenced.

Methods and systems disclosed herein are directed at predicting a useris leaving a target state or is not at or going to achieve a targetstate and then assisting the user to reach the target state. Predictionis done using electronic sensing of at least one of a physiologicalstate with a wearable sensor/device or collected from a separatedevice/database (e.g. a smartphone, a fitness monitor, a smart watch, asmart speaker, a smart eyewear, a connected vehicle, or a smartheadphones); or a contextual data of the user, to determine an emotionaland/or physiological state, and then generating a transcutaneousvibratory output directed at addressing or avoiding the predictedstate(s), and delivering it as needed. The transcutaneous vibratoryoutput may have multiple segments, each having variable parameters. Aswith all embodiments herein, if the transcutaneous vibratory output isnot effective to assist the user to avoid the predicted state or enter atarget state, it may be modified (e.g. such as by varying one or more ofthe variable parameters), discontinued, or a second transcutaneousvibratory output may be generated and commenced.

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state using their sensory thresholds, both lower andupper, as bounds for the transcutaneous vibratory output that isgenerated. When an input a state is made to a processor in communicationwith a transducer, such as the user has a particular disorder, thetransducer is caused to generate transcutaneous vibratory output in aselected pattern, based on the identified disorder, at a sensorythreshold value at or above the subject's sensory threshold fortranscutaneous vibratory output. Various values and ranges for perceivedbeat, perceived pitch and sensory threshold limitations are disclosed inthe treatment of various hypoarousal and hyperarousal symptomsassociated with imbalances in autonomic nervous system (ANS).

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state and storing at least one of contextual orbiometric data of the user while the user is in the target state as abaseline state. For example, the user may desire stimulation to achievea “pumped state” (optimal performance state), and may indicate so in auser interface, and a transcutaneous vibratory output may be generatedto achieve the state. When the user achieves the state, such as by theirindication of so achieving in a user interface or by their turning itoff, biometric and contextual data are stored for the future. Perhapsthe contextual data includes the user's location at a gym. If thislocation is sensed again by a processor in communication with thetransducer, the transcutaneous vibratory output that was generated toachieve the “pumped state” may be automatically commenced.

Systems disclosed herein are configured to assist a subject to reach atarget state using a coordinated system of transducers. Each transducerin the system emits a transcutaneous vibratory output in accordance witha desired target state of the user, where each transducer emits one ofthe wave pattern for perceived pitch or the wave pattern for perceivedbeat, or each transducer in the system emits a different transcutaneousvibratory output in a pattern (e.g simultaneously, sequentially,alternating, coordinated). Each transducer in the system may be worn ona different body part. As with all embodiments herein, if thetranscutaneous vibratory output emitted by any of the transducers is noteffective to assist the user to enter a target state, it may be modified(e.g. such as by varying one or more of the variable parameters),discontinued, or a new transcutaneous vibratory output for one or moreof the transducers may be generated and commenced. In some embodiments,the processor of a first transducer is programmed to modify the firsttranscutaneous vibratory output pattern based on data received from asecond transducer. As with any of the embodiments herein, the processorof the transducer may be in communication with one or more sensors, withother systems, devices, or transducers and any processor thereof, orwith a remote server.

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state using transcutaneous vibratory output andanother modality (e.g. a sensory stimulation (e.g. visual, olfactory,tactile, etc.), a therapy (e.g. psychotherapy, physical therapy,massage)). Based on a condition of the user, determined automaticallyvia sensing (e.g. physiological, biometric) or input by a user, atranscutaneous vibratory output is generated to assist in resolving thecondition. Further, a sensory stimulation may be selected based on theassessed condition of the user or the vibratory output selected. Thesensory stimulation may further be commenced by a processor incommunication with a controller of a system or sensory output devicedelivering the sensory stimulation. In some embodiments, the sensorystimulation is applied with the stimulation device.

Methods and systems disclosed herein are directed at assisting a subjectusing transcutaneous vibratory output to mitigate the negative effectsof a drug (e.g. MDMA, psilocybin, cannabis, an anti-depressant, ananti-anxiety drug, an anti-psychotic, and a psychoactive drug) in thetreatment of a mental health condition. Methods may includeadministering a drug to the subject in a therapy session and identifyingany effects that are counterproductive to the therapy session (e.g.anxiety, restlessness). If any are identified, such as by a therapistinput, a sensor (e.g. physiological or biometric), or by user input, atranscutaneous vibratory output and/or variable parameters used togenerate the vibratory output may be selected that mitigates or reducesthe negative effects. The vibratory output may be generated and applied.A sensory stimulation may also be applied to the subject, by thesubject, in response to identification of any negative effects.

Methods and systems disclosed herein are directed at providingtranscutaneous vibratory output for a therapeutic session based on anevent to be experienced by a user. Data regarding the event may beobtained through input on a user interface or through communication ofthe event to a processor that creates therapeutic session parameters.Based on the event, the processor may assign a set of contiguous outputsegments to the event and instruct a transducer, or send a processor inassociate with the transducer instructions, to generate the segments,whereupon the transducer generates the segments. The therapeutic sessionmay be further modified in accordance with the event. The event may beat least one of an athletic event, an entertainment event, apsychotherapy session, or a stress inducing event, and the dataregarding the event may be based on location, received from a trafficapplication, collected by a physiological sensor, is a change in theevent, a change in a traffic pattern. Methods may further includeadministering a drug during the psychotherapy session.

Methods and systems disclosed herein are directed at assisting a subjectto sleep using transcutaneous vibratory output. During transcutaneousvibratory stimulation intended to prime the user to enter a sleep state,a physiological sensor worn by or near the user provides data to aprocessor in communication with a transducer regarding if the subject isin a pre-sleep state or a sleep state, and based on the data, theprocessor may alter one or more variable parameters of the stimulationpattern emitted by the transducer or power off the transducer. Inembodiments, certain variable parameters may be tapered down if the dataindicate the user is close to sleep or already sleep. Tapering down mayinclude reducing the frequency of the perceived pitch and/or increasingthe interval of the perceived beat and/or reducing the intensity and,optionally, maintaining the reduced frequency and/or increased intervaland/or reduced intensity for a period of time. In some embodiments, thetherapeutic stimulation pattern includes two or more oscillations, onein a range of approximately 1 to approximately 100 Hz, and the otherinitially differs from the first frequency by approximately 0.0001 toapproximately 1 Hz, that collectively form a beat output.

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state using transcutaneous vibratory output. Aprocessor at least one of within or in electronic communication with amobile device is in electronic communication with a transducer and asensor sensing biometric data of the user. The transducer receives atarget state for a user and generates a first transcutaneous vibratoryoutput. Biometric data are received from the sensor and a determinationis made by the processor if the user has at least one of achieved or notachieved the target state, and if the user has not achieved the targetstate, the processor is further programmed to determine the user'scurrent state. The mobile device is caused to (i) generate outputindicating whether the user has achieved the target state, and (ii) ifthe user has not achieved the target state, generate output (e.g.visual, audible, or tactile) to guide (e.g. pulsing heart, a depictedbreathing rhythm) the user to achieve the target state.

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state using transcutaneous vibratory output deliveredthrough or by furniture. A system may include a housing comprising aseat/seat back that includes a transducer. A physiological sensor maydetermine a state of alertness of the occupant of the seat and theprocessor may control the transducer in response, such as to cause astimulation that is directed at causing wakefulness in a user. Avehicular sensor may sense a vehicle operation parameter (e.g. vehiclemotion, windshield wipers activated) wherein the processor may use thevehicle operation parameter to control the transducer.

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state using transcutaneous vibratory output deliveredthrough or by an infant seat. The infant seat comprises a transducerlocated at least partially within the housing and adapted to deliver avibratory stimulation to an occupant (e.g. an infant) of the seat. Amicrophone may sense an utterance from the infant and transmit it to aprocessor using a data transmitter. The processor may be locatedremotely from the housing or in the housing itself. An indicator may beadapted to respond to a signal from the processor to provide an output,such as through a mobile device display or a display on the infant seat.The processor may determine a beginning utterance volume and durationand a current volume and duration and determine a magnitude ofdifference between the values and generate a signal indicative ofwhether additional vibratory stimulation is needed, and optionally, aduration or intensity of the vibratory stimulation. The signal may betransmitted to one or more processors associated with the system. Theprocessor may further cause the transducer to generate a transcutaneousvibratory output.

Methods, systems, and kits disclosed herein are directed at causing anepigenetic change using transcutaneous vibratory output. An epigeneticmarker is measured in the user, wherein the epigenetic marker is atleast one of a regulation of a protein or a gene or a methylation,acetylation, or phosphorylation status of a gene or a histone. Atranscutaneous vibratory output is provided to a user, optionallyrepeatedly, which is directed at causing a user to achieve a targetstate, then the measurement of the epigenetic marker is repeated toidentify a change in an aspect of the epigenetic marker as a result ofsubjecting the user to the first transcutaneous vibratory output or aseries of vibratory outputs over time. Target state achievement may beverified by a physiological sensor and/or user input. The transcutaneousvibratory output may be continued, altered, or terminated in response todata regarding the epigenetic marker. In place of measuring theepigenetic marker, a proxy for an epigenetic change may be measured,such as a stress indicator. The stress indicator may be a presence, anabsence, or a frequency of one or more positive or negative words incommunications or social media postings. The stress indicator may be avocal tone, a pitch, and a vocal rate, a time to reach the target stateafter continued use, or a dwell time in the target state after continueduse. A kit may comprise the stimulation device, a physiological sensorand a user interface, and may further comprise a biological samplecollection device, wherein the user is prompted, through the userinterface, to provide a biological sample for epigenetic change testingif the indication is that the user has achieved the target state.

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state using dynamic transcutaneous vibratory output toprevent habituation. Preventing habituation may include tapering orramping a transcutaneous vibratory output that is generated and appliedto a user to assist them in reaching a target state. With eachsubsequent execution of a session, any of the tapering rate, ramp rate,highest value or lowest value may be modified in order to preventhabituation. Further, the tapering or ramping may involve tapering orramping one or more different variable parameters during subsequentexecutions of the session. In other embodiments, the initialtranscutaneous vibratory output used for subsequent executions of thesession may comprise at least one variable parameter that is differentfrom those used in the previous session.

Methods and systems disclosed herein are directed at determining auser's sensory threshold for transcutaneous vibratory output. A lowersensory threshold is established by delivering a transcutaneousvibratory output to a portion of a user's body and gradually reducing anintensity of the transcutaneous vibratory output until the userindicates, such as on a user interface, that it is barely noticeable,and then delivering subsequent transcutaneous vibratory output, such asto assist a user in reaching a target state, at or within a desiredstandard deviation of the lower sensory threshold. An upper sensorythreshold is established by delivering a transcutaneous vibratory outputto a portion of a user's body and gradually increasing an intensity ofthe transcutaneous vibratory output until the user indicates that it isdistracting, and then delivering subsequent transcutaneous vibratoryoutput, such as to assist a user in reaching a target state, at orwithin a desired standard deviation of the upper sensory threshold. Insome embodiments, establishing a sensory threshold is done by deliveringa transcutaneous vibratory output to a user and providing a userinterface for a user to adjust the perceived intensity, such as to apoint where it is barely noticeable or distracting. The user interfacemay provide prompts to guide the user through the adjustments inestablishing the sensory threshold. A final value of the perceivedintensity is stored after the user completes adjustment, wherein thefinal value is the sensory threshold.

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state using transcutaneous vibratory output thattapers down or ramps up. A value of one or more of the first perceivedpitch, the first perceived beat, and the first perceived intensity ofthe transcutaneous vibratory output is at an upper value. One or more ofthe first perceived pitch, the first perceived beat, and the firstperceived intensity are tapered down to a lower value over a firstperiod of time and, optionally maintained or discontinued when reachingthe lower value. Tapering may be done using a first tapering rate toreach one or more intermediate values between the highest and lowestvalues, wherein multiple rounds of tapering and maintaining may be donebetween the highest and lowest value. Other tapering rates may be usedbetween intermediate values and between intermediate values and thelowest value. In ramping up, a value of one or more of the firstperceived pitch, the first perceived beat, and the first perceivedintensity of the transcutaneous vibratory output is at a lower value.One or more of the first perceived pitch, the first perceived beat, andthe first perceived intensity are ramped up to a higher value over afirst period of time and, optionally maintained or discontinued whenreaching the higher value. Ramping up may be done using a first rampingrate to reach one or more intermediate values between the lowest andhighest values, wherein multiple rounds of ramping and maintaining maybe done between the lowest and highest value. Other ramping rates may beused between intermediate values and between intermediate values and thehighest value.

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state using transcutaneous vibratory output includecontrolling external devices based on state achievement, such asdetermined by a sensor, user input, or third party data, or in order toachieve a state. A target state of the user is determined andtranscutaneous vibratory output is generated and applied to a user. Anaction related to control of an external device is caused to at leastone of facilitate entry into the desired target state or in response toreaching the desired target state. The action may be adjusting aparameter of an environment or a device, such as turning off/on lights,changing room temperature, lowering/raising window shades, turningon/off music, triggering a secondary stimulating device in amattress/pillow/seat, triggering an aromatherapy, or triggering aparticular color. The action may be adjusting at least one of a contentdelivery setting or a content filter for applications andcommunications, wherein the content filter determines the types ofcontent delivered to the user. The action may be adjusting a socialmedia setting, such as a do not disturb setting. The action may beprompting the user to perform a certain a task.

Methods and systems disclosed herein are directed at assisting a subjectto reach a target state using audible vibratory output. Upon obtaininginput of a target state or determining the need to achieve a targetstate based on sensors or third party data, an audible output isgenerated and delivered to the subject to assist the subject inachieving the target state, the audible output having variableparameters comprising variable parameters including a perceived pitch, aperceived beat, and a perceived intensity. As with the transcutaneousvibratory output, a user or a processor may be able to adjust any one ofthe variable parameters, cause the output to be dynamic, taper, ramp,discontinue or maintain the output, calibrate the output, establishsensory thresholds for audible output, and other methods and systemsdescribed herein. In embodiments, the audible output may comprisemultiple segments, each optionally having different values for perceivedpitch, perceived beat, and intensity. In some embodiments, the audibleoutput may be accompanied by transcutaneous vibratory output.

These and other systems, methods, objects, features, and advantages ofthe present disclosure will be apparent to those skilled in the art fromthe following detailed description of the preferred embodiment and thedrawings.

All documents mentioned herein are hereby incorporated in their entiretyby reference. References to items in the singular should be understoodto include items in the plural, and vice versa, unless explicitly statedotherwise or clear from the text. Grammatical conjunctions are intendedto express any and all disjunctive and conjunctive combinations ofconjoined clauses, sentences, words, and the like, unless otherwisestated or clear from the context.

BRIEF DESCRIPTION OF THE FIGURES

The disclosure and the following detailed description of certainembodiments thereof may be understood by reference to the followingfigures:

FIG. 1 depicts a system for facilitating neural state transitions.

FIGS. 2A and 2B depict block diagrams of a stimulation device.

FIG. 3 depicts various embodiments of devices that provide stimulation.

FIG. 4A depicts a wave pattern with a perceived pitch.

FIG. 4B depicts a sine wave-shaped envelope.

FIG. 4C depicts a waveform with the envelope, or beat, shown in FIG. 4B.

FIG. 5A depicts a frequency with a perceived pitch and FIG. 5B depictsan envelope.

FIG. 5C depicts a waveform generated by modulating the wave in FIG. 5Aby the envelope in FIG. 5B.

FIG. 6 depicts a coordinated set of transducers delivering stimulationdescribed herein.

FIG. 7 depicts a waveform with a changing maximum intensity.

FIG. 8 depicts a waveform with increasing perceived pitch.

FIG. 9 depicts a waveform with increasing beat frequency.

FIG. 10 depicts a waveform with increasing perceived pitch, perceivedbeat and intensity.

FIG. 11 depicts a system for equalization and compression.

FIG. 12 depicts distinct phases of a vibration.

FIG. 13 depicts a process for calibration.

FIG. 14 depicts a process for operating a stimulation device.

FIG. 15 depicts a process for mitigating negative side effects of atreatment.

FIG. 16 depicts a process for promoting epigenetic change.

DETAILED DESCRIPTION

An apparatus with transducers may deliver stimulation and/or treatmentto a portion of a subject, such as in response to an input, that isintended to allow the subject to achieve a target state, such as aneural state. Such “stimulation” will be described herein more fully.however, the stimulation shall be briefly referred to here astranscutaneous vibratory stimulation. However, individuals reside inecosystems with many inputs, devices, and sources of stress such thatachieving and maintaining any one state, recovering from states, orbeing resilient to certain states, such as stress, may be difficult.This apparatuses, methods and systems described herein provide solutionsto certain problems, such as how to: mitigate the negative effects ofco-treatment with a stimulation protocol, predict a particular neuralstate onset and treat proactively with particular waveforms, utilizedata external to the apparatus to determine a subject's state and/orachievement of a target state post-stimulation/treatment, learn a user'sstimulatory preferences and needs to generate a stimulation/therapyplan, determine a user's sensory threshold, develop protocols to avoidhabituation to stimulation or stimulation patterns, taper or ramp up astimulation protocol, fine tune the stimulation necessary to achieve atarget state based on real-time or longitudinal data, program the deviceto deliver patterns/sessions of stimulation, facilitate entry into asleep state, provide visual feedback to a user of a state and/or atreatment protocol to facilitate entry into a state, coordinatestimulation from a plurality of transducers, control external devicesbased on aspects of the stimulation therapy, provide ameditation/mindfulness application, provide stimulation therapy to auser via any connected hardware, provide stimulation therapy in variousproducts (e.g. seat/furniture, mobile seat, gaming seat, infant seat orother furniture, cradle/bassinet/crib, bedding, wearable/garment,eyewear, augmented reality eyewear, wearable pet product,gaming/entertainment devices), provide haptic protocols of multiplefrequencies, provide treatment using audible frequencies, provide thetransducers as a component of another device (e.g. in a clasp/portion ofa smartwatch band that is communicatively coupled to a smartwatch orother device), measure and track epigenetic changes as a result oftreatment, or the like. Certain solutions described herein are directedto solving the aforementioned problems.

Terminology that is relevant to this document includes the following:

As used in this document, the singular forms “a,” “an,” and “the”include plural references unless the context clearly dictates otherwise.Unless defined otherwise, all technical and scientific terms used hereinhave the same meanings as commonly understood by one of ordinary skillin the art. As used in this document, the term “comprising” (or“comprises”) means “including (or includes), but not limited to.” Whenused in this document, the term “exemplary” is intended to mean “by wayof example” and is not intended to indicate that a particular exemplaryitem is preferred or required.

In this document, when terms such as “first” and “second” are used tomodify a noun, such use is simply intended to distinguish one item fromanother, and is not intended to require a sequential order unlessspecifically stated. The term “approximately,” when used in connectionwith a numeric value, is intended to include values that are close to,but not exactly, the number. For example, in some embodiments, the term“approximately” may include values that are within +/−10 percent of thevalue.

When used in this document, terms such as “top” and “bottom,” “upper”and “lower”, or “front” and “rear,” are not intended to have absoluteorientations but are instead intended to describe relative positions ofvarious components with respect to each other. For example, a firstcomponent may be an “upper” component and a second component may be a“lower” component when a device of which the components are a part isoriented in a first direction. The relative orientations of thecomponents may be reversed, or the components may be on the same plane,if the orientation of the structure that contains the components ischanged. The claims are intended to include all orientations of a devicecontaining such components.

An “electronic device” or a “computing device” refers to a device orsystem that includes a processor and memory. Each device may have itsown processor and/or memory, or the processor and/or memory may beshared with other devices as in a virtual machine or containerarrangement. The memory will contain or receive programming instructionsthat, when executed by the processor, cause the electronic device toperform one or more operations according to the programminginstructions. Examples of electronic devices include personal computers,servers, mainframes, virtual machines, containers, gaming systems,televisions, digital home assistants and mobile electronic devices suchas smartphones, fitness tracking devices, and wearable virtual realitydevices. Electronic devices also may include Internet-connectedwearables such as smart watches, smart clothing and smart eyewear.Electronic devices also may be embedded in products that are designed tobe used by a human while sleeping, such as a pillow, mattress, mattresstopper or bedding (sheets, pillowcase, blanket, etc.). In aclient-server arrangement, the client device and the server areelectronic devices, in which the server contains instructions and/ordata that the client device accesses via one or more communicationslinks in one or more communications networks. In a virtual machinearrangement, a server may be an electronic device, and each virtualmachine or container also may be considered an electronic device. In thediscussion below, a client device, server device, virtual machine orcontainer may be referred to simply as a “device” for brevity.Additional elements that may be included in electronic devices will bediscussed below in the context of FIGS. 1 and 2.

The terms “processor” and “processing device” refer to a hardwarecomponent of an electronic device that is configured to executeprogramming instructions. Except where specifically stated otherwise,the singular terms “processor” and “processing device” are intended toinclude both single-processing device embodiments and embodiments inwhich multiple processing devices together or collectively perform aprocess.

The terms “memory,” “memory device,” “data store,” “data storagefacility” and the like each refer to a non-transitory device on whichcomputer-readable data, programming instructions or both are stored.Except where specifically stated otherwise, the terms “memory,” “memorydevice,” “data store,” “data storage facility” and the like are intendedto include single device embodiments, embodiments in which multiplememory devices together or collectively store a set of data orinstructions, as well as individual sectors within such devices.

As used herein, the term “treat”, “treating” or “stimulating” refers toimproving the mood and/or physiology and/or symptoms of a subject,including enhancing a person's positive outlook or suppressing aperson's negative outlook. Such may refer to a person's psychologicalwell-being, including but not limited to their emotional, cognitive, andmotivational states.

The term “depression” refers to a morbid sadness, dejection, ormelancholy, and includes general physical conditions in which a personexhibits symptoms such as sleep problems, appetite problems, anhedoniaor lack of energy, feelings of worthlessness or hopelessness, difficultyconcentrating, and suicidal thoughts.

As used herein, the term “side effect” refers to undesirablephysiological and/or psychological effects of a medical treatment on asubject. Side effects may be reduced by decreasing their severity, bydecreasing their frequency, or by decreasing both their severity andfrequency. The stimulation of the autonomic nervous system byapplication of vibrational stimulus (as discussed herein) may reduceside effects from various medical treatments, including, withoutlimitation pharmaceutical agents, drugs, cannabis, psychotherapy,surgical procedures, or the like.

Throughout this specification, the stimulation described is referred toas transcutaneous vibratory stimulation or transcutaneous vibratoryoutput. One form of such transcutaneous vibratory stimulation ortranscutaneous vibratory output may be haptic or tactile stimulation,wherein “haptic” and “tactile” may be used in the alternative. While inother embodiments, the stimulation (transcutaneous or not) may beaudible (and thus experienced audibly by the subject). Such audibleembodiments are designed to achieve a target state through the subject'shearing or audiation. All such stimulation may be referred to as“therapy” or “therapeutic output”.

A “subject” may be referred to as a “user” or a “wearer” of the device.In some instances, there is a “subject”, i.e., the person or organism towhom the vibratory stimulation is applied, and a “user” who may beseparate from the subject. Therefore, the user may be the subject or notdepending on the context of the description or the accompanying claims.

In embodiments throughout this disclosure, and as will be furtherdescribed herein, a system for treating a subject may include astimulation device that includes a tactile transducer configured to emittranscutaneous vibratory output to a portion of the subject's body incommunication with a processor. The system may optionally include asensory output device, also in communication with a processor. Theprocessor may be in communication with a memory that has instructionsstored thereon that when executed cause the processor to determine atranscutaneous vibratory output and, optionally, a sensory output,wherein the processor causes the tactile transducer to emit atranscutaneous vibratory output determined by the processor, thetranscutaneous vibratory output comprising a perceived pitch and aperceived beat. An application in communication with the processor mayreceive data from the stimulation device and embedded or associatedsensors and devices, and may further control the stimulation device andembedded or associated sensors and devices. In embodiments, theprocessor may optionally cause the sensory output device to output atleast one of a visual, an olfactory, or an audible output. The systemmay also include one or more sensors, such as a physiological sensor ora biometric sensor generating data indicative of a condition of theuser, wherein the processor is further configured to determine atranscutaneous vibratory output or a sensory output based on the dataindicative of a condition of the user.

The system may include controllers, processors, network infrastructure,cloud-based storage, input/output devices, servers, client devices(e.g., laptops, desktops, terminals, mobile devices, and/or dedicateddevices), sensors, actuators, data storage or subscriptions, and/orcomponents configured as computer-readable instructions that, whenperformed by a processor, cause the processor to perform one or morefunctions. The system may be distributed across a number of devices,including wearable devices, and/or the functions of the system may beperformed by one or more devices in cooperation.

The system may include application programming interfaces thatfacilitate connection among the components of the system and between thesystem to entities that are external to the system and facilitateoperation, programming, and use of the system by a user. Any componentor interface to the system may be controlled by or have control over acontroller. In some embodiments, a mobile device being operated by auser may form a portion of the system as described herein.

Certain considerations for the person of skill in the art, indetermining the configuration of components, circuits, controllers,and/or devices to implement the system as described herein include,without limitation: the availability of sensed or collected data; acommunication status with one or more sensors; the knowledge of one ormore sensory thresholds; the proximity of a suitable transducer to aportion of a user's body; the availability of a suitable transducer; ifinstructions are to be provided directly by a user or if the system isto be triggered; if another treatment modality is being usedconcomitantly (e.g. pharmacological, sensory, or therapeutic), or thelike.

While specific examples of the system and considerations are describedherein for purposes of illustration, any system benefitting from thedisclosures herein, and any considerations understood to one of skill inthe art having the benefit of the disclosures herein, are specificallycontemplated within the scope of the present disclosure.

Referring now to FIG. 1, an embodiment of a system for facilitatingneural state transitions is depicted. In the system, a stimulationdevice 102 may be programmed to provide acoustic and/or vibrationalenergy, such as tactile, haptic, or transcutaneous vibratory energy,that may be transmitted to a subject 114 wearing the therapeutic device.The stimulation device 102 may be an apparatus with a transducer adaptedto deliver a stimulation to a portion of a subject intended to allow thesubject to achieve a state. In certain embodiments, the stimulus maycomprise oscillations of different frequencies, such as sine waveoscillations, that results in a beat frequency that is output to thesubject. In an embodiment, the stimulation device may be configured, viaa processor, to generate a transcutaneous vibratory output to assist auser in achieving a target state, the transcutaneous vibratory outputcomprising a first perceived pitch, a first perceived beat, and aperceived intensity. The stimulation device 102 may be controlleddirectly through a user interface of the stimulation device 102, such asthrough a controller 212, or may be controlled through an applicationexecuting on a mobile device or computing device. In embodiments, remoteservers or applications running in the cloud 104 may be used to control,configure or otherwise communicate with a processor of the stimulationdevice 102. I/O devices 110 (e.g. third-party devices or software) maybe used to provide data for processing by the stimulation device 102and/or associated applications or systems. Likewise, the stimulationdevice 102 may provide and/or transmit data to I/O devices 110.Mathematical analysis of the collected data from all available sourcesmay be performed by a processor of the stimulation device 102 orapplication/remote server in communication with the stimulation deviceto, among other things, generate predictions of a state transition.External devices/systems 108, such as a mobile phone or application(e.g. care provider application) may be used to control the stimulationdevice 102 or may in turn be controlled by the stimulation device 102 orits output. Any of the system components may be in communication witheach other via the cloud, directly or by some other relay. The systemmay include a remote server 112, wherein the stimulation device 102 maycommunicate with the remote server 112 to receive data, instructions,programming or firmware updates, and the like.

Sensors 118 may be external to or integrated with the stimulation device102 and may be used to obtain feedback from the user before, during, orafter the stimulation device's 102 operation, may be configured tocollect biometric, physiological, movement, and/or contextual data fromthe subject 114 or the subject's environment to be used to determine thestate of the subject, provide data useful for altering a vibratoryoutput, establish a baseline state of the subject, predict a user'sfuture state, establish a sensory threshold, and in any of the otherembodiments described herein. Sensor 118 readings may be used by thedevice and/or associated applications as feedback with which topotentially alter the pattern, frequency, intensity and/or duration oftranscutaneous vibratory output (or audible output, as the case may be),as will be further described herein. Physiological sensors may measureECG, temperature, heart rate, heart rate variability (e.g. which is aproxy for autonomic nervous system tone and emotion regulationcapability), respiration rate, blood volume pulse, blood pressure,transcutaneous cortisol, blood glucose, vocal tone/pitch/vocal rate(e.g. such as with a microphone), galvanic skin response, gamma bandEEG, pupil size/reactivity, brain activity (whole brain EEG), muscleactivity, facial expressions, temperature, sweat amount, sweatcomponents, cerumen components, or the like. Environmental sensors usedto further assess user's state may include calendar activity, socialmedia postings, screen time/phone usage, texting frequency, screen tappressure, or game play frequency. Digital image frames may be receivedfrom an imaging sensor (e.g. camera) that can capture video and/or stillimages, wherein the camera may be associated with the stimulation deviceor a separate device. The system also may include a positional sensor560 and/or motion sensor 570 to detect position, movement, activity orlocation of the user or stimulation device. The positional sensor 560and/or motion sensor 570 may be worn by the user or in a device carriedby the user. In embodiments, motion sensors 570 may include gyroscopesor accelerometers. In embodiments, positional sensors 560 may include aglobal positioning system (GPS) sensor device that receives positionaldata from an external GPS network. Contextual data, which may be used inany of the disclosed embodiments, may derive from content of socialmedia, a navigation application, a calendar application, a movementtracker, location tracker, direction of travel, an amount of usage ofthe mobile device, keystrokes input into the mobile device, or a projectmanagement application. Data collected by any of the sensor devicesdescribed herein that may be used to modify an aspect of thestimulation, discontinue the stimulation, or otherwise be used in afeedback loop. The sensor device may be embedded in a sensing wearabledevice such as a watch, wristband, bracelet, shirt, medical device (e.g.blood pressure cuff, pulse ox, thermometer, light stimulation, soundstimulation), exercise/activity monitor, or other wearable item.Alternatively, or in addition, a sensor device may be embedded in aseparate device that is touching or proximate to the user, such as apillow, mattress, blanket or other bedding.

The stimulation device 102 may be configured to provide acoustic and/ortranscutaneous vibratory stimulation to the subject 114 and may beconfigured to modulate the autonomic nervous system. In variousembodiments, the stimulation device 102 may be configured to apply thestimulation to one or more body parts of the subject 114 by being wornor placed in proximity to, without limitation, the human's wrist, ears,neck, ankles, hips, knees, feet, sternum, chest, back, whole body, orthe like. In certain embodiments, the stimulation device 102 is adaptedto be disposed in a portion of a subject, such as by implantation, todeliver a stimulation, such as through implantation of the device 102 orwhen the device 102 is integrated with another implantable, such as aninsulin pump, pacemaker, or the like. Thus, the parts of the stimulationdevice 102 that emit vibrations may be included in the form of awearable device such as a band that wraps around the appropriate bodypart (wrist, ankle, head, feet, etc.), a set of headphones or earbuds, ahat or cap, a wristwatch, a shirt, or other wearable devices, or animplantable device. In some embodiments, the stimulation device 102 mustbe touching the body to be effective, while in other embodiments, thestimulation device 102 is effective without having to actually contactthe body.

In an embodiment, and referring now to FIG. 3, the stimulation device102 may be embodied in a wearable (which may be Internet-connected), awatch, a smart watch, a smart phone, a computing device, an anklet, achest strap, a smart clothing/garment (hat/shirt, scarf, earmuffs, hairband), a shoe/shoe sole/shoe insert, headphones/earbuds/earpiece (e.g.audio stimulation through earpiece), a smart eyewear, an eye mask, aseat, an infant seat/cradle/furniture, a vehicle seat with sensors indashboard/seat/wheel, a pillow, a bed, a mattress, a mattress topper orbedding (e.g. sheets, pillowcase, blanket, weighted blanket, animalblanket etc.), a yoga mat, a pet product, a dog bed, a pet collar, aready-made pod, or other clothing or furniture where the sensors andtransducers/stimulators can be disposed or embedded. For example, asystem to soothe an infant may include a seat with at least onestrategically-placed transducer (e.g. cushion, mattress, mattresstopper, bedding, pillow, stuffed animal) adapted to emit vibrationcomprising a perceived pitch, perceived beat, and a perceived intensityselected to induce a soothed state. For example, the system may beembodied in bedding, such as a mattress topper or pillow, wherein thesystem may deliver therapeutic stimulation to facilitate sleep,including taper functionality and/or sleep detection-turn-offfunctionality. Sensors may also be embedded in the bedding to trackentry and/or exit from sleep, provide feedback on the effectiveness ofthe stimulation (e.g. respiration changing, cries diminishing), or toprovide a signal to commence stimulation (e.g. microphones detecting acry). A speaker may be included to play lullabies, heartbeat sounds,white noise, or other soothing output. In another example, a system mayinclude a transducer located in a seat or seat back, such as an immobileseat or one in a transportation setting, wherein the transducer isconfigured to deliver a transcutaneous vibratory stimulation to anoccupant of the seat. A physiological sensor may be used determine astate of alertness of the occupant of the seat and a processor maycontrol the transducer in response. Where the seat is in an automobile,a vehicular sensor may sense a vehicle operation parameter, wherein theprocessor further utilizes the vehicle operation parameter to controlthe transducer. For example, if the vehicular sensor indicates that theuser is closing their eyes while the car is still in motion, a processorin communication with a transducer in the seat may cause it to turn onand deliver stimulation directed at wakefulness. In yet another example,a pet or animal collar may have an embedded transducer and processor,wherein the processor can be remotely controlled by a separate device oran application executing on a smartphone, mobile device, computer, orthe like to deliver stimulation through the transducer, as describedherein, to an animal wearing the collar. Sensors, such as physiologicalsensors, microphones, cameras, or the like, may be integrated with thecollar or associated with it to provide feedback, as described herein,to the processor. In any of the embodiments, control of generating anddelivering the stimulation may be through the embodiment itself usingfirmware embedded in an integrated or associated processor, or may bethrough software or an API executing on a computing facility.

In an example, when the stimulation device 102 is embodied in a smartphone, an application on a smart phone computing device may be used tocontrol it to emit stimulation, either as transcutaneous vibratoryoutput, audible output, or both. The stimulation may be generated by oneor more of a vibratory motor or speaker of the smartphone. Inembodiments, other content may be delivered by the smart phone or otherapps may be used to cause other actions or control other devices duringthe therapeutic output. In another example, the stimulation device 102embodied in a ready-made pod may include modular parts or kits or partssold to manufacturers of other products such as seats, sleeping PODS,baby seats, pet collars, and the like to be incorporated intodesigns/products. API's and wireless connectivity could be a componentof the ready-made pod sold to manufacturers to provide control options.In an embodiment, the stimulation device 102 may be embodied inaugmented reality or virtual reality eyewear or other equipmentassociated with these embodiments. For example, a transducer may beincorporated to the arms of the eyewear so as to deliver tactilestimulation, and optionally, audible stimulation to the user.Stimulation that is both tactile and audible may be synergistic orcomplementary. In embodiments, the augmented reality eyewear may beprogrammed to deliver content in conjunction with the stimulation.

FIG. 2A and FIG. 2B illustrates a block diagram of an examplestimulation device 102. As shown in FIG. 2A, the stimulation device 102may include one or more transducers 201, a controller 212, and aprocessor 202 in a housing 210. The stimulation device 210 may be incommunication with (as shown in FIG. 2A), or optionally include (as inFIG. 2B), a communications interface 203, a power source 204, anoptional user interface 205, and a memory 206.

The one or more transducers 201 may be any device that may transmitvibrational and/or acoustic energy from an energy source to a subject inthe form of stimulus. Examples of transducers may include, withoutlimitation, bone conductors (e.g. such as a bone conductor in smart oraugmented reality eyewear), tactile transducers, transcutaneousvibratory transducers, linear resonant actuators, rotational motors,bass shakers, or audio transducers (e.g., speakers). While not shownhere, the transducer 201 may receive the desired stimulation signal froma driver that amplifies and filters it so that an appropriate voltageand current signal is applied to the transducer 201.

The processor 202 may be configured to control one or more functions ofthe stimulation device 102 such as, without limitation, application of asuitable stimulation to a subject, frequency control of the appliedstimulation, processing of feedback received from the sensor device,communication with a user or an external system, or the like. In someembodiments, the processor 202 may be configured to control thestimulation applied (e.g., frequency, time duration, intensity, etc.)based on, without limitation, readings from the stimulation device 102,sensors 118, 208, 570, 560, user input, or any other information, orcombinations thereof. The processor 202 may communicate with each of theother components of the stimulation device 102, via for example, acommunication bus or any other suitable mechanism. The processor 202 maybe controlled by an application executing on a mobile device, computingdevice or remote server 112.

In certain embodiments, the stimulation device 102 may be configured toapply the desired stimulation to a subject as transcutaneous vibrationover a discrete period of time. In some embodiments, it may be acontinuous application of frequency sound. The length of time duringwhich the stimulation is applied may vary from situation to situation,depending on factors such as the nature and severity of the conditionbeing treated: the size, age, gender, and overall condition (physicaland psychological) of the subject, etc. Alternatively, and/oradditionally, the duration may be defined based on input received from asensor, the user, or third party data. In general, the duration ofapplication may be in the range of 1 minute to two hours, and optionallyin the range of 5-15 minutes or 1-5 minutes. Alternatively, a duty cycleby which the stimulation may be delivered may be an oscillating orpulsed manner e.g. by employing repeated sequences of seconds or minuteson and off, resulting in intermittent (for example, sporadic: 30 secondson-30 seconds off) or (for example non-sporadic: 30 seconds on-10seconds off), alternating delivery and cessation of delivery of thetherapeutic stimulation. In embodiments, the signal may be a series ofdiscrete pulses with additional vibrations between pulses. The dutycycle may be programmed to result in staccato vibrations.

In one or more embodiments, a communications interface 203 may beconfigured to facilitate communication of data into and out of thestimulation device 102. In some embodiments, the communicationsinterface 203 may include, without limitation, a WiFi transceiver, aBluetooth transceiver, an RFID transceiver, an Ethernet port, a USBport, and/or or any other type of wired and/or wireless communicationinterfaces. The communications interface 203 may be configured totransmit data to and receive data from computing devices, mobiledevices, and/or networks that are not included in the stimulation device102. For example, communications interface may couple the stimulationdevice 102 to an application running on a user device such as a mobiledevice.

In certain embodiments, the user interface 205 may include any type ofinput and/or output devices that permit a user to input commands into orreceive information from the stimulation device 102. The optional userinterface 205 may include elements configured to receive commands orinput parameters, or to be used to check or change settings. Examplesinclude a tactile input such as a keypad or touch screen, a microphone,dedicated buttons, dials or switches, or other devise. In embodiments,the user interface 205 may be adapted to receive gestural input orverbal input.

The user interface 205 also may include elements configured to outputdata such as a display, light emitting diodes (LEDs), transcutaneousvibratory/haptic facilities, or an audio speaker. Output from thestimulation device 102 may be on a display of the device 102 itself, ona mobile device, on a third-party device, to an application such as acare provider application, or the like. In embodiments, the output maybe visual feedback provided to the user in conjunction with deliveredtherapy. The processor may be in communication with a mobile device anda sensor sensing biometric data of the user, as well. During delivery oftranscutaneous vibratory output to the user, the sensor may collectbiometric data of the user. The processor may use the biometric data todetermine whether the user has at least one of achieved or not achievedthe target state, and if the user has not achieved the target state, theprocessor is further programmed to determine the user's current staterelative to the target state. Based on these determinations, theprocessor then causes the mobile device to (i) generate outputindicating whether the user has achieved the target state, and (ii) ifthe user has not achieved the target state, generate output to guide theuser to achieve the target state.

In another embodiments, the visual feedback of the user's state may beprovided on a display of the stimulation device itself. For example, aprocessor, either in the stimulation device or separate from it, may bein communication with the transducer and the display of the stimulationdevice and a sensor. The processor causes the transducer to generate afirst transcutaneous vibratory output and then determines based onbiometric data from the sensor whether the user has at least one ofachieved or not achieved a target state, and if the user has notachieved the target state, the processor is further programmed todetermine the user's current state relative to the target state. Theprocessor may cause the display to display an indication of whether theuser has achieved the target state, and if the user has not achieved thetarget state, display information to guide the user to achieve thetarget state. In other embodiments, the visual feedback of the user'sstate may be provided in an application executing on a smartphone,mobile device, computer, or the like.

In any of the embodiments, the output may be at least one of visual,audible, or tactile. For example, the visual output may be an image of apulsing heart roughly mirroring the actual heartbeat of the individual.In embodiments, the pulsing heart may be configured to slow down orspeed up in accordance with a sensed heart rate. The output to guide theuser may be generated based on the user's current state relative to thetarget state. The output to guide the user may communicate a recommendedbreathing rhythm. If the processor determines that the user has not yetachieved the desired target state, the processor makes a determinationthat the output needs to be modified and causes the transducer togenerate another transcutaneous vibratory output that may vary in one ormore variable parameters relative to the first vibratory output.

The user interface 205 may permit a user to control the operation of thestimulation device 102, define settings (e.g., frequencies, intensity,time duration, etc.) of the stimulation device, receive informationabout operations of the stimulation device, troubleshoot problems withthe stimulation device, or the like.

The system's user interface may include inputs that enable a user toactivate and/or turn off the transducers, to modify stimulation patternsincluding modifying the herein described parameters of the output,and/or to indicate that a particular pattern is agreeable or notagreeable. The system may determine a user's usage pattern, such aspatterns most frequently used and typical durations of usage, and savethis data to a user profile so that the system can automatically adjustto the user's preferences. For example, if a particular therapy has adefault duration and the user does not typically turn the therapy offbefore the end of that duration, the system may retain that durationwhen applying the therapy again. However, if the user typically turnsthe stimulation off before the default duration ends, the system mayadjust the default duration for that user to match the average or meanduration that the user actually applies the therapy, optionally onlyconsidering a threshold previous number or times of application whencalculating the mean or average. The system may also use other functionsthat are based on actual usage data to determine the duration.Similarly, a particular therapy may have a default intensity level, theuser interface may permit the user to vary the intensity level, and thesystem may automatically adjust the default to match the user's mean oraverage selected intensity level.

In some embodiments, the power source 204 may be configured to providepower to the stimulation device 102. The power source 204 may includeone or more of a rechargeable battery, a non-rechargeable battery, asolar cell, a chemical reaction power generator, a power input port thatconnects to an external power line, or any other device configured toprovide power to the stimulation device 102 and its components.

The housing 210 may be configured to secure the transducer 201 at thesite of application of the stimulation on a subject. For example, if thestimulation will be applied to the wrist of a subject, the housing maybe in the form of a wristband. Similarly, if the stimulus will beapplied to various points on the back of a subject, the housing may be amattress, a mattress topper, a sheet or blanket, a wearable shirt, aseat or seat cushion, a body wrap, or other item that contacts thesubject's back. Some components of the device such as the transducer 201may be on or outside of the housing, or sonically conductive leads mayextend from the housing from the transducer 201.

In some embodiments, audible frequencies may be delivered by thestimulation device itself, by a connected audio device, or incombination with tactile vibration. An application or other software maybe used to control and/or cause to emit the audible frequency and/orvibration frequencies over the stimulation device or a peripheraldevice.

FIG. 1 also depicts various components that may be included in thesystem, either in the stimulation device or in a mobile device orcomputing device that is in communication with the stimulation device.In some embodiments, an electrical bus may provide for electroniccommunication among various components and a controller 120 may controlsuch communications. Processor 505 may be configured to performcalculations and logic operations required to execute programminginstructions. As used in this document and in the claims, the terms“processor” and “processing device” may refer to a single processor orany number of processors in a set of processors that collectivelyperform a set of operations, such as a central processing unit (CPU), agraphics processing unit (GPU), a remote server, or a combination ofthese. Read only memory (ROM), random access memory (RAM), flash memory,hard drives and other devices capable of storing electronic dataconstitute examples of memory devices 525. A memory device may include asingle device or a collection of devices across which data and/orinstructions are stored. The processor may be embedded in thestimulation device or may be in a separate device.

An optional display interface 530 may permit information to be displayedon a display device 535 in visual, graphic or alphanumeric format. Anaudio interface and audio output (such as a speaker) also may beprovided. Communication with external devices may occur using variouscommunication devices 540 such as a wireless antenna, an RFID tag and/orshort-range or near-field communication transceiver, each of which mayoptionally communicatively connect with other components of the devicevia one or more communication system. The communication device 540 maybe configured to be communicatively connected to a communicationsnetwork, such as the Internet, a local area network or a cellulartelephone data network.

In an embodiment, a user interface 545 may enable receipt of data frominput devices 550 such as a keyboard, keypad, a mouse, a joystick, atouchscreen, a touch pad, a remote control, a pointing device, dedicatedbuttons, dials, switches, and/or microphone.

In an embodiment, the one or more transducers 201 may be configured toprovide acoustic and/or vibrational energy as a wave pattern that may betransmitted to the subject, the acoustic and/or vibrational energycomprising the stimulation described herein, which is configured tocause a user to achieve a target state or maintain a current state. Aphase accumulator or a numerically controlled oscillator may be used togenerate waveforms. Data storage 580 may include data related toparameters for fundamental vibration generation, data related totreatment protocols including associated therapies and stimulation, dataon how to interpret physiological and/or contextual data, data onendpoints used to trigger stimulation, user profile data including knownphysiological parameters, sensory thresholds, baseline states,performance states, typical locations, or the like, manually collecteddata from users, epigenetic data using data collected in part from abiological sample collection device 590, and data from monitoring mobiledevice and application usage. or the like. Parameters of fundamentalvibration generation are frequency of the perceived pitch, frequency ofthe perceived beat, and intensity (or maximum intensity). The frequencyof the perceived pitch defines a base (carrier) tone. The perceived beatfrequency defines an envelope which modulates the amplitude of the basetone creating a fundamental vibration. This modulation involvesmultiplicative combination, as will be described herein. Intensity isthen used when scaling the fundamental vibration for delivery via thetransducers. In embodiments, the envelope is a sine wave whose frequencyis half that of the perceived beat. Intensity correlates with the user'sawareness of the stimulation, wherein the minimum necessary intensity isthe point where the user becomes aware of the waves/vibrations and themaximum intensity is where the user no longer tolerates the stimulation.Developing the fundamental vibration via this approach has the benefitof augmenting the user experience by facilitating access to a variety ofstimulation patterns. This approach also makes the generation of certainstimulation patterns, such as (i.e. taper, ramp, and/or intensitychanges) far more efficient than it would be using interferencepatterns, including for example, by decreasing the processing needs togenerate those stimulation patterns. The multiplicative approach towaveform generation improves the efficiency, in practice, of layering ofadditional frequencies over the use of interference patterns. Forexample, the most basic form of the waveform is one perceived pitch andone perceived beat, however, as discussed herein more than one perceivedpitch and/or more than one perceived beat may be used to generate awaveform. The multiplicative approach described herein provides animprovement over an approach using interference patterns (also describedherein) by making it far more efficient to layer, such as by, includingmore than one perceived pitch and/or more than one perceived beat. Theimproved efficiency of the multiplicative approach over an approachutilizing interference patterns is rooted in the fact that using morethan two interference patterns results in high levels ofunpredictability, due to the physics of combining frequencies. Complexinterference patterns are unpredictable, and computationallyinefficient, whereas the multiplicative approach described hereinmitigates this concern. The multiplicative approach also providesenhanced user control over waveform generation, and ultimately theuser's experience, by providing an enhanced means to adjust or selectmultiple variables and segments of vibratory stimulation.

For example, the graph shown in FIG. 4A depicts 1 second of a wavepattern with a perceived pitch 402 of 10 Hz, that is, the wave patternoscillates 10 times per second. The graph shown in FIG. 4B depicts asine wave-shaped envelope 404 whose frequency is 1 Hz. Perceived beatfrequency is always twice the frequency of the envelope. Thus, in thisexample, the perceived beat frequency is 2 Hz. When the base tone shownin FIG. 4A is modulated by the envelope 404 shown in FIG. 4B, theresultant wave pattern/fundamental vibration, shown in FIG. 4C, exhibitsa perceived beat frequency of 2 Hz (i.e. the user perceives that thepattern repeats twice a second). Eqn. 1 is used to find the shape of thewave pattern for a given frequency of a perceived pitch:signal_base_tone=sin(2.0*π*freq_perceived_pitch*t).  [Eqn. 1]

This equation seeks to find the base tone's signal, or amplitude, ateach timepoint. In Eqn. 1, the freq_perceived_pitch is the frequency ofthe base tone in Hz. For the example shown in FIG. 4A, the frequency ofthe base tone is 10 Hz and the time varies along the X-axis. In thisexample, between 0.02 and 0.03 seconds, the wave has reached its maximumpositive signal (1.0), then heads back down to zero between 0.05 and0.06 seconds, reaches its maximum negative signal between 0.07 and 0.08seconds (−1.0), then heads back up to zero by around 0.1 seconds. Thevalues for Eqn. 1 establish the range of values and shape of the wavepattern shown in FIG. 4A.

Eqn. 2 is used to find the shape of the envelope for a given perceivedbeat frequency:signal_envelope=sin(π*freq_perceived beat*t)  [Eqn. 2]

In Eqn. 2, the freq_perceived beat is the frequency of the perceivedbeat in Hz. For the example shown in FIG. 4B, the frequency of theperceived beat is 2 Hz and the time varies along the X-axis. In thisexample, at 0.25 seconds, the wave has reached its maximum positivesignal (1.0), then heads back down to zero at about 0.5 seconds, reachesits maximum negative signal at 0.75 seconds (−1.0), then heads back upto zero by around 1 second. In this example, the wave pattern is a sinewave generated at 1 Hz, as depicted in FIG. 4B.

Combining the two wave patterns results in the base tone being modulatedby a sine-wave based envelope. To achieve the wave pattern shown in FIG.4C, the wave patterns depicted in FIGS. 4A and 4B are multiplicativelycombined in accordance with Eqn. 3:signal_fundamental_vibration=signal_base_tone*signal_envelope.  [Eqn. 3]

In Eqn. 3, the results of Eqn. 1 and Eqn. 2 are multiplied for eachtimepoint to generate the signal_fundamental_vibration at thatparticular timepoint. For example, at 0.23 seconds, the value ofsignal_base tone is 1.0 and the value of signal_envelope is 1.0 andtheir product, or signal_fundamental_vibration, is 1.0, which is themaximum positive signal for the combined wave patterns. This maximumsignal is reached again at 0.77 seconds, during the second portion ofthe 2 Hz envelope.

Ultimately, the fundamental vibration is translated into a signal thatis sent to a transducer, wherein the signal is limited to a range ofvalues that is appropriate for the transducer being used and the givenintensity.

In this embodiment, intensity is a scalar value between 0 and 1, whichattenuates the amplitude of the fundamental vibration.signal_output=signal_fundamental vibration*intensity  [Eqn. 4],

Signal_output is defined as the signal that is output by the transducer.

In some embodiments, intensity need not be interpreted as an attenuationof amplitude, but rather the power of the signal (in g-force), measuredat the transducer. The signal that is sent to the transducer or speakeris an electrical signal measured by voltage. The transformation fromvoltage into signal power may not be linear. In order to maintain aconsistent level of power, the amplitude may be adjusted relative to thephysics of the transducer. As an example, for base signals whosefrequencies are near the resonant frequency of the transducer, theoutput signal may need to be attenuated.

In embodiments, the fundamental vibration may be further modulated. Inan additional example, FIG. 5A depicts a base tone and FIG. 5B depictsan envelope. FIG. 5C is the fundamental vibration generated bymodulating the wave in FIG. 5A by the envelope in FIG. 5B. Referring nowto FIG. 7, depicted is a waveform with a perceived pitch of 20 Hz thatis unaltered over the charted time period and a perceived beat frequencyof 1 Hz, which is also unaltered over the charted time period. Themaximum intensity, however, is changing over the time period shown. Aline drawn from the apex of the first beat to the apex of the last beatindicates that the change has a negative slope, which translates to anapproximate rate of about 0.009%. In this example, a programmer may haveset the perceived pitch and perceived beat frequency of the wave patternand a starting intensity and indicated that the intensity should beramped down at a rate of 0.009% over time without altering perceivedpitch or perceived beat. Thus, the ramp down changes the maximumintensity, without altering the envelope.

In the wave shown in FIG. 8 (e.g. a sweep (perceived pitch)), theperceived pitch starts low and increases linearly to a maximum intensitywith no change in the perceived beat. In the wave shown in FIG. 9 (e.g.a sweep (envelope)), the pitch and intensity are unchanged over time butthe beat frequency increases over time. In the wave shown in FIG. 10,the perceived pitch, perceived beat and intensity are all increasingover time.

The waveforms depicted above are output via the transducer describedherein. Modifying the resultant waveforms parameters of pitch, beat, andintensity can be done to achieve different base tones/envelopes andtherapeutic ends.

In embodiments, the transducer 201 may provide the stimulation in theform of: a base tone or wave with perceived pitch in the range of 1-500Hz and an envelope with a perceived beat frequency that modulates thebase tone in the range of 0.0001-20 Hz with a perceived intensity thatis determined based on each individual user's sensory threshold. Thelower sensory threshold is minimum intensity level at which the userbecomes aware of the waves/vibrations. The upper end of the sensorythreshold may be an intensity level of the stimulation at which the userwould have difficulty ignoring the vibrations or find them distracting.As described elsewhere herein, determining the individual user's sensorythreshold may be done via at least one of three methods: a) calibration;b) active data collection (via brief survey questions in-app); and c)passive data collection (via monitoring mobile device and app usage).

In the setting of users' having different sensitivities to the frequencyof the base signal, the intensity can be implemented to modulate thepower of the transducer output signal to ensure the users' perceivedintensity is consistent across base frequencies.

In certain embodiments, stimulation provided by the device 102 may be acombination of sine wave oscillations of different frequencies thatresults in a beat frequency that is output to the subject. Thecombination of a main frequency and a modulation frequency results in abeat output that provides to a user a feeling of slow or fast waves ofstimulation at a frequency determined to be arousing or calming based ona treatment being administered, as elsewhere described herein, and/orthe physiology of the subject. The applied stimulation may include asingle modulation frequency or multiple modulation frequencies. Thegeneration of fundamental vibrations using interference patterns is analternative embodiment than that described with respect to using a basetone whose intensity is modulated by an envelope. In this alternativeembodiment, the values for perceived pitch and frequency of the signal's‘beat’ are derived from the two frequencies of the beat interferencepattern, in accordance with the following equations.freq_perceived_pitch=(freq_interference1+freq_interference2)/2  [Eqn. 5]freq_perceived_beat=freq_interference1−freq_interference2  [Eqn. 6]

In this alternative embodiment, the beat interference pattern may arisefrom pre-generated sine waves using signal data extracted from WAV audiofiles.

For example, the transducer 201 may provide the simulation in the formof: (i) a main frequency of 1-500 Hz modulated by a modulation frequencythat differs from the main frequency by about 0.0001-10 Hz; (ii) a mainfrequency of 1-100 Hz modulated by a modulation frequency that differsfrom the main frequency by about 0.0001-1 Hz; or (iii) other frequencyvalues within the ranges listed above. The combination of the mainfrequency and the modulation frequency results in an interference wavepattern and a beat output. The interference wave pattern and beat outputmay provide a user a feeling of slow waves of stimulation at a frequencydetermined to be arousing or calming based on the treatment beingadministered and/or the physiology of the subject. The appliedstimulation may include a single modulation frequency or multiplemodulation frequencies. In embodiments, one transducer 201 may deliverthe main frequency while another transducer 201 delivers the modulationfrequency, or perceived beat. The acoustical or vibrational energy asused in this disclosure may be a low frequency sound (acoustical energy)or vibration (mechanical energy). For example, the sonic vibration thatis delivered may be in the form of a primary frequency of approximately1-100 Hz. In some embodiments, the primary frequency may beapproximately 1-40 Hz, approximately 1-30 Hz, approximately 1-33 Hz, orother values in those ranges. In some embodiments that result ininterference patterns, the primary frequency may be combined with amodulation frequency, or more than one modulation frequency, that isapproximately 0.0001-1 Hz different from the primary frequency. The twofrequencies together may form a beat frequency output. For example, inapplications designed to maintain the subject in a state of sleep, theprimary frequency may be in a range of 1-40 Hz, while the modulationfrequency may differ from the primary frequency by about 0.0001-0.1 Hz.In one example, the stimulation device 102 delivers vibration output inthe form of a main oscillation between 20-300 Hz and a modulationoscillation between 0.05-10 Hz, which together form a beat output. Thestimulation device 102 may be designed to deliver output in the form ofvibration, electrical output (e.g. voltage, such as a PWM waveform),audio output, or combinations thereof. In examples where the output iscombined, the selected frequencies may be chosen to be complementary orsynergistic.

Referring now to FIG. 12, a wave may three phase types: synchronization,transformation, and stabilization. The segments are a sequence offundamental vibrations starting from an initial vibration thattransforms gradually to a goal fundamental frequency. In thesynchronization phase, the stimulation device may emit the fundamentalvibration corresponding to the physical/emotional state reported by theuser when defining a wave. This initial vibration will be played aproportion of the overall application after which the wave will switchto 0 or more transformation/stabilization phase pairs. During atransformation phase, the parameters of the fundamental vibration aregradually modified until the parameters match those of the goalfundamental vibration. In stabilization, the vibration is played until asynchronization state is achieved where there is no expected change inmood or energy and may be maintained. By employing these phases,stimulation therapy can be aligned with a current state of the userfirst then gradually transform down to a middle state then to goalstate. In the boundary case, a wave is equivalent to a fundamentalvibration. In the boundary case, the initial and goal fundamentalvibrations are the same and the length of the wave is infinite. Inembodiments, the phase parameters for the initial or the goal vibrationmay be Freg_(Tone)=1-300 Hz, Freq_(Envelope)=0.001-10 Hz, intensity is anumber between 0 and 100, and the duration is in seconds.

In some embodiments, the transformation from initial vibrationparameters to goal vibration parameters may be linear. The phaseparameters of synchronization and stabilization phases may haveidentical initial and goal vibrations. Fade-in/fade-out effects may beachieved by using Initial and goal vibrations with identical frequenciesbut different intensities (0 initial for fade-in, 0 goal for fade-out).Abrupt change may be done by using zero segments having zero duration.

In use cases where the frequencies are changing over time, the systemmay dynamically adjust the intensity of the vibrations to equalize theintensity level throughout. That is, and referring to FIG. 11, as thefrequency generated by a wave generator 1102, such as a phaseaccumulator or numerically controlled oscillator, changes over time,there may be no significant perceptible change in the intensity leveldetectable by the user. Equalization refers to adjustments, which may bemade by an equalizer 1104, made to the maximum amplitude of the signalto generate the signal at the same subjective level of intensity acrossall frequencies. Adjustments may be via a scaling factor between zeroand one. Signals may also be compressed. Compression, which may be doneby a compressor 1108, refers to adjustments made to the signal afterequalization to map the signal values to the range of intensitiesidentified by the user during calibration, the lower threshold tagged as‘just being able to feel’ and the upper threshold being ‘highest thatcan be tolerated’. After compression, the signal is sent to adigital-to-analog converter 1110. Included in the compression step is acheck to ensure the output voltage to the speaker 1112 does not exceed arange, such as +−0.8 volts.

In embodiments, the system 100 may employ a coordinated system ofmultiple transducers 201. Each transducer in the system emits atranscutaneous vibratory output in accordance with a desired targetstate of the user, where each transducer emits one of the wave patternfor perceived pitch or the wave pattern for perceived beat, or eachtransducer in the system emits a different transcutaneous vibratoryoutput in a pattern (e.g simultaneously, sequentially, alternating,coordinated). For example, a first transducer may be disposed in awearable applied to a user's wrist delivering a first stimulationpattern in a manner as described herein. A second transducer may beapplied to a different part of the user's body, such as for example theneck, and may deliver a second stimulation pattern. The secondstimulation pattern may be the same or it may be different. Inembodiments, a first transducer may be disposed in a stimulation deviceand a second transducer may be disposed in a third-party device such asa mobile device. Note that the transducer in the mobile device may be ofthe type already incorporated into the mobile device to emit vibrationor sound. The third-party device may also be a wearable. In embodimentsembodiment, a first transducer may be disposed in a third-party wearableand a second transducer may be disposed in a device associated with thewearable, such as in a watch band or watch band clasp of the third partywearable. In embodiments, the transducer is disposed in a clasp/portionof a smartwatch band that is communicatively coupled to a smartwatch orsmart device, wherein the clasp or band comprises at least onetransducer for delivering oscillations/vibratory stimulation to asubject's wrist, including a ventral part of the wrist. The timing,intensity, beat output, pitch output of the two devices may be selectedto achieve a particular coordinated pattern, such as a particularsyncopation or rhythm across the transducers. Stimulation may becoordinated between the two transducers to deliver stimulation, inembodiments, that has similar effects as stimulation delivered by asingle device with two transducers. Coordination may be done via aprocessor associated with the stimulation device, a third party device,a mobile device, or the like. Whether it is a single transducer or acoordinated set of transducers, stimulation therapy can be effectivewhen the transducer is placed anywhere on or in proximity to the user'sbody. In alternative methods of generating the transcutaneous vibratoryoutput, one transducer may deliver a main frequency while anothertransducer delivers a modulation frequency.

Referring now to FIG. 6, a system to deliver vibratory therapy to a usermay include a first transducer 1302 adapted to emit a firsttranscutaneous vibratory output 1308 and a second transducer 1304adapted to emit a second transcutaneous vibratory output 1310. The firsttransducer may be worn on a first part of a user's body while the secondtransducer is worn on a second part of the user's body. The user is ableto select a target state desired by the vibratory therapy using a userinterface in communication with the first transducer and/or the secondtransducer, wherein the transcutaneous vibratory output patterns may bebased on the target state. In embodiments, the user interface is runningon an application on a mobile device. A processor may be in electroniccommunication with the user interface, the first transducer, and thesecond transducer. The processor may be part of the first or secondtransducer, or may be in a separate device. In an embodiment, the firsttransducer may be in electronic communication with the secondtransducer. The processor may be programmed to cause the transducers togenerate transcutaneous vibratory output patterns and emittranscutaneous vibratory outputs in accordance with those patterns, eachtranscutaneous vibratory output comprising a perceived pitch, aperceived beat, and a perceived intensity, each of which may be the sameor different.

In embodiments, the first transcutaneous vibratory output pattern andthe second transcutaneous vibratory output patterns may be emittedsimultaneously, sequentially, or in an alternating pattern. Inembodiments, the first transcutaneous vibratory output pattern and thesecond transcutaneous vibratory output patterns may be independent ofone another or coordinated with one another. In some embodiments, thesecond transcutaneous vibratory output is discontinued while the firsttranscutaneous vibratory output is emitted, or vice-versa. In anembodiment, the processor may be programmed to modify the firsttranscutaneous vibratory output pattern by varying the first perceivedpitch, and further, to modify the second transcutaneous vibratory outputpattern by varying the second perceived pitch. In an embodiment, theprocessor may be programmed to modify the first transcutaneous vibratoryoutput pattern by varying the first perceived beat, and further, tomodify the second transcutaneous vibratory output pattern by varying thesecond perceived beat. In an embodiment, the processor may be programmedto modify the vibratory patterns by varying the perceived intensity. Inan embodiment, the processor of the first transducer may be programmedto modify the first transcutaneous vibratory output pattern based ondata received from the second transducer.

Fundamental vibrations whose variable parameters are perceived pitch, orfrequency of the base (carrier) tone, frequency of the perceived beatand maximum intensity (simply referred to as intensity) may be used inmethods and systems to assist subjects in reaching a target state. Thetranscutaneous vibratory output may be applied to a portion of thesubject's body as described herein to assist the subject in achievingthe target state. In accordance, with input of a desired target state ofthe subject, transcutaneous vibratory output may be generated havingvariable parameters comprising a perceived pitch, a perceived beat, anda perceived intensity.

The stimulation device 102 and/or associated application may beprogrammed to deliver stimulation whose parameters are selected to causea user to reach a target state (e.g. arousal, relaxation, asleep, lowerheart rate, lower blood pressure, calm, focus, flow, presence of being,asleep, wakeful, relaxed, aroused, euphoric, etc.), facilitate entryinto a target state, treat a condition (e.g. anxiety; insomnia; chronicpain; chronic stress; autism; depression, psychosis, headache, migraine,autoimmune disorders; hypertension; disorders relating to hypoarousalsuch as narcolepsy, fatigue, excessive daytime somnolence, chronicfatigue syndrome, constipation, catatonia, metabolic syndrome, eatingdisorders, obesity, hypotension, dysautonomia, attention deficitdisorder, attention disorders that are characterized by decreased orunbalanced activity of the sympathetic nervous system over time (e.g.wherein treatment causes increased attention to inside the body byincreasing parasympathetic tone relative to sympathetic tone, orincreased attention to stimuli external to the body by increasingsympathetic tone relative to parasympathetic), motion sickness, vertigo,vasovagal reactions, disorders of metabolism including insulininsensitivity (type 2 diabetes mellitus) and metabolic syndrome,autonomic disorders, autoimmune disorders, or anemia), mitigate a sideeffect of a treatment, and the like. Each target state may be defined bycertain parameters, such as physiological parameters or biometricparameters. For example, a calm state may be identifiable based on aheart rate below 60 bpm, an HRV above 80, a high frequency of positivewords on social media postings and texts, a low speaking volume, or thelike. In another example, an agitated state might be identifiable basedon a heart rate over 100 bpm, an HRV below 40, a high-pitched speakingvolume, increased use of negative words, and the like.

Configuring the stimulation to achieve a target state or maintain acurrent state may comprise adjusting one or more of the variableparameters. Any of the parameters of the stimulation may be modified,either individually or in combination of two or more. Modification mayinclude increasing or decreasing one or more of perceived pitch,perceived beat, or intensity. For example, in assisting a target inreaching a state of flow (peak performance), the parameters of thetranscutaneous vibratory output used to reach the state of flow may bederived from a lookup table, may be based on transcutaneous vibratoryoutput that previously successfully facilitated entry into a flow statefor the subject, may be done in real time in accordance with sensorfeedback, may be done manually, or the like. For example, the variableparameters may be modified using a user interface of the stimulationdevice or of an associated device controlling the stimulation device. Inembodiments, during application of the transcutaneous vibratory output,at least one of the variable parameters may be varied to generate asecond transcutaneous vibratory output to be applied to a portion of thesubject's body to assist the subject in achieving the target state.

In embodiments, the parameters of the transcutaneous vibratory outputmay be dynamically adjusted to prevent habituation. In certainembodiments, the beat frequency output is dynamic and not constant inorder to prevent habituation by the subject. The dynamic nature may beinduced based on data collected by the sensor device 118, based on userfeedback, and/or automatically. For example, if the data collected bythe sensor device indicates that the balance between the sympathetic andparasympathetic nervous systems has improved over a period of time butis not yet at the optimal level, the primary frequency may be taperedgradually rather than an immediate shut off. In subsequent attempts toreach the same target state, one of the variable parameters (e.g. pitch,beat, intensity), or the tapering or ramping rate may be varied fromthose used in a previous session to prevent habituation. Alternatively,and/or additionally, the user interface of the system may include aninput field in which a user can select modes that will increase ordecrease the speed by which the frequencies taper from an upper startingpoint to a lower ending point. In yet another embodiment, the dynamicnature may be induced automatically. As noted above, the system may beprogrammed to resume the stimulation (or stop it from turning off) ifdata from one or more of these sensors exceeds a threshold value.

In embodiments, the system may be programmed to receive user input anduser feedback to manually initiate, terminate or adjust stimulation,such as in a user interface of the stimulation device, in a user inputdevice, verbally indicating the state to a microphone input, in anapplication controlling the stimulation device, such as an applicationexecuting on a mobile device (e.g. smartphone, smart watch, smarteyewear, etc.), or the like. For example, a user may input a currentstate and/or a desired target state. The user's current state orcondition may be indicated by the user (e.g. “I feel stressed”). Astimulation protocol or transcutaneous vibratory output may be selectedbased on the desired target state, based on the current state indicatedby the user, and optionally, based on the current state relative to thedesired target state. Based on the input, the transducer of thestimulation device generates a first transcutaneous vibratory output tobe applied to a portion of the user's body to assist the user inachieving the desired target state, the first transcutaneous vibratoryoutput comprising a first perceived pitch, a first perceived beat, and aperceived intensity. Determining if the user has achieved the targetgoal state may also be done subjectively, such as by receiving an inputfrom the user of goal achievement (e.g. “I feel good”), as describedherein, or by the user manually discontinuing stimulation. Throughoutthe stimulation, the user may also input or be prompted to input if theyare still feeling that they have not reached the target state, if theyare still in the initial state, or if they feel they are in betweenstates. If the user has not achieved the desired target state, a secondtranscutaneous vibratory output may be generated, such as with thestimulation device, and delivered to the user in achieving the desiredtarget state. The second transcutaneous vibratory output may havevariable parameters (e.g. perceived pitch, perceived beat, and perceivedintensity) that are different from those of the first transcutaneousvibratory output.

Determining current state or condition or goal state achievement mayalso be done: using biometric data, using sensed physiological data(e.g. HRV, GSR, heart rate, respiration rate, etc.), using sensorreadings in comparison to a target physiological profile, in accordancewith usage patterns, based on third party data, based on social media,or the like. In various embodiments, a target state may be indicated,such as in a user interface or using data collected by the sensordevice(s) that indicates the need for a target state. In embodiments, atarget state may be a particular health index. Health index may be anaggregate of various health-related measures, such as blood pressure,heart rate, HRV, ratio of HR/HRV, or the like.

In embodiments, data collected by the sensor device(s) may be used asfeedback to initiate and/or control the application of the stimulus, ora first transcutaneous vibratory output, to the subject, via thestimulation device 102. Additionally, and/or alternatively, the datacollected by the sensor device may be used to select and personalize theapplication of stimulation to the subject 114 based on the datacollected by the sensor device. For example, the frequency ranges,stimulation patterns, stimulation application times, stimulationapplication duration, or the like may be personalized to a user.Continuous or periodic monitoring using sensors may be done, optionallyalong with comparison to parameters for a known/stored state. Forexample, if a user is attempting to reach a target state of beingasleep, sensed parameters associated with that state may be high HRV,low movement, and low audible sound. In this case, one or more of amotion sensor, biometric or physiological sensor, or microphone may beused to monitor the user for possible entry into the state of sleepbased on the group, or part of the group, of sensed parameters incomparison to known ranges of the sensed parameters. In another example,if the target state is wakeful and sensors indicate low HRV, stimulationmay be initiated to address hypoarousal. In yet another embodiment,sensors indicating high HR and low HRV in the absence of physicalactivity may trigger a therapeutic stimulation for hyperarousal. Thesensor device may use this sensor feedback to continue operation of thedevice if the user has not reached the target state or an expected state(e.g. Generally, fast, high intensity vibration patterns may increaseHR, respirations, blood pressure, and sweat while decreasing HRV.Generally, slow, gentle, low intensity vibration patterns may decreaseHR, respirations, blood pressure, and sweat while increasing HRV.), asevidenced by sensors, terminate operation if the user has reached thetarget state, begin a tapering of stimulation if sensors indicate theuser is approaching the target state, generate a second transcutaneousvibratory output, or the like. The second transcutaneous vibratoryoutput may have variable parameters (e.g. perceived pitch, perceivedbeat, and perceived intensity) that are different from those of thefirst transcutaneous vibratory output.

In embodiments, a system to alter the mood of a user may include a userinput device, a stimulation device which includes a transducer adaptedto emit transcutaneous vibratory output, a physiological sensor sensinga physiological parameter of the user, and a processor in electroniccommunication with the user input device, the transducer and thephysiological sensor. The system may accept input of a desired state ofthe user, and in response, cause the transducer to generate a firsttranscutaneous vibratory output to be applied to a portion of the user'sbody to assist the user in achieving the desired target state. In thisembodiment, the first transcutaneous vibratory output may includeparameters including a first perceived pitch, a first perceived beat,and a perceived intensity. The physiological parameter of the user maybe used to determine whether the user has achieved the desired targetstate. If the user has not achieved the desired target state, thetransducer may generate a second transcutaneous vibratory output to beapplied to a portion of the user's body to assist the user in achievingthe desired target state, the second transcutaneous vibratory outputhaving parameters including a second perceived pitch, a second perceivedbeat, and a perceived intensity, which may be a second perceivedintensity.

In an embodiment, stimulation may be terminated once a state has beenreached as indicated by passive sensing (e.g. derived from otherinformation sources) or active sensing (e.g. accelerometer indicates nomovement, respiration rate indicates sleep, position, sensors indicate ahealth index/level). In an embodiment, stimulation may be resumed whensensors indicate the state has changed. The system may be programmed toresume stimulation (or stop it from turning off, or extend a taperingtime) if data from one or more of these sensors exceeds a thresholdvalue, or alternatively, based on an elapsed time. The system may beprogrammed to initiate a program when a particular sensor reading isreceived.

In certain aspects, sensors may determine a current contextual orphysiological condition for the user and stimulation may be initiated,terminated or adjusted based on one or more detected states. Forexample, if sensors indicate stress (e.g. based on a health index),other data may be used to modulate turning on/off the stimulation. In anexample, if an accelerometer indicates that the user is moving at anexercise rate, then the sensor readings are likely not indicating stressbut rather reflect exercise. In an embodiment, if sensors indicateslowing down of movement at a particular time, that may be interpretedas getting ready for sleep, and the stimulation device's sleep routinemay commence. In an embodiment, if sensors indicate the user is in a carbut is experiencing drowsiness, the stimulation device 102 may be causedto commence delivery of stimulation configured to promote wakefulness.

In an embodiment, determining if a user has reached a target or goalstate as a result of a stimulation may be done via user input, usingsystem data, passive user data or sensing wearables (e.g. smart watch,medical device (e.g. blood pressure cuff, pulse ox, thermometer)),exercise/activity monitor, or other wearable item, or may be done usingexternal and/or third party sources, such as third-party data,third-party devices, SaaS applications, health and fitness informaticsapplications, health and fitness APIs, hospital data systems, socialmedia posts, communications, and the like. For example, a processor ofor associated with a stimulation device may be programmed to receive auser's social media posts and commentaries and assess the language usedfor tone and emotion. In some embodiments, any combination of userinput, internal sensing, or external data or sources may be used todetermine if the user has reached goal state. The external and/or thirdparty sources may provide data on physiological parameters (e.g. bloodpressure, HRV, GSR, respiration rate, etc.). In some embodiments, basedon determining if the goal state has been reached from external and/orthird party sources, a second stimulation may be generated anddelivered/applied to the subject to assist in reaching or maintainingthe target state. In some embodiments, based on determining if the goalstate has been reached from external and/or third party sources,stimulation may be discontinued or extended.

Configuring the stimulation to achieve a target state or maintain acurrent state may comprise generating stimulation of more than onesegment, such as to obtain a session of stimulation having a series or aconcatenation of stimulation patterns to achieve a desired state. Insome embodiments, the session may be associated with an event, such asan entertainment event, an athletic event, a stress-inducing event, apsychotherapy session, or the like, and each segment is selected toproduce an “overall” experience conducive to the event or session. Forexample, a session for mitigating anxiety of air travel may havemultiple segments, such as a segment that is executed while the subjectis waiting to board, then another while on board but awaiting takeoff,one during takeoff, one during flight, and the like. The user maymanually indicate when the status of air travel has changed so that anext segment is executed. Data, such as third party data may be used toindicate when the status of air travel has changed so that a nextsegment is executed, such as for example, air traffic control andairline status data. Sensors may be used to indicate the status of theair travel in order to move from one segment to another, such as amicrophone to hear announcements, a connected camera in smart eyewear,an altimeter to indicate altitude, or the like. In embodiments, dataregarding an event to be or currently being experienced by the user maybe obtained by a user interface, a contextual, biometric orphysiological sensor, third party data or applications, and the like.Physiological sensors may include respiration, temperature, GSR, SpO₂,spirometry, EEG, ECG, EMG, heart rate, HRV, CO₂, motion, blood pressure,glucose, or the like. Biometric sensors may capture data regardingfingerprints, visual/facial cues, vocal tone, vocal pitch, the iris, orthe like. Contextual sensors may capture data regarding the geospatialenvironment, location, meteorology and weather, air pollution/qualitymonitoring, flood monitoring, or the like. In some embodiments, the dataregarding the event is a change in the event, such as a change in atraffic pattern, a delay in takeoff, a significant change in theweather, or the like.

Other examples of events where a session of stimulation may be usefulinclude at athletic events, during public speaking sessions, during aspeech or presentation, during a commute, for the treatment of aparticular disorder (e.g. PTSD), for a desired feeling or desiredoutcome for the day, or the like. In the case of a commute, for example,data, such as from a traffic, GPS, or navigation application, may beused to determine speed, location, volume of surrounding traffic, andthe like, and these data may be used to create the therapeutic sessionparameters and may also be used to move the session from segment tosegment, such as one segment when traffic is moving, and another whentraffic is at a crawl.

In embodiments, the segments of the stimulation may each be defined byone or more parameters including a perceived pitch, a perceived beat,and an intensity. In generating each segment, a value for each of thevariable parameters may be assigned for each segment. Data regarding anevent to be experienced by the user may be communicated to a computerprocessor that is configured to create therapeutic session parameters.The therapeutic session parameters may be created by assigning a set ofcontiguous output segments for the event, and based on the event,assigning a perceived pitch of transcutaneous vibratory output and aperceived beat of transcutaneous vibratory output to each outputsegment. A transducer generates the transcutaneous vibratory output forthe therapeutic session based on the therapeutic session parameters,such as upon receiving the therapeutic session parameters from thecomputer processor. The therapeutic session parameters may be generatedthrough machine learning of past responses to past events and paststimulations useful in reaching a goal state during or in spite of theevent.

In embodiments, the segments may commence immediately after a priorsegment has ended, or the stimulation may ramp up or taper down in atleast one parametric aspect between segments. In embodiments, one ormore of the variable parameters for each segment may be programmed inaccordance with a target state, wherein programming may take advantageof a lookup table, may be based on transcutaneous vibratory output thatpreviously successfully facilitated entry into the target state for thesubject, may be done in real time in accordance with sensor feedback,may be done manually, or the like.

In some embodiments, the therapeutic session may be accompanied by othertherapies or associated interventions, such as the delivery of compounds(e.g. pharmaceuticals, psychoactive agents, etc.), playing of music,back massage, release of certain aromas, dimming of lights, or the like.

In order to effectively provide stimulation, the device 102 and/orassociated algorithm(s) may first be calibrated. Calibration may proceedin a number of ways, as will be described. In one aspect, calibrationmay comprise establishing characteristics of a baseline, non-stressedstate and a health index, or signatures of various non-baseline states.For example, through initial use of the stimulation device andcontinuous recording of various parameters associated with the user,either through embedded or associated sensors, the user may indicatewhen they are stressed and non-stressed so that the algorithm associatesthe stored parameters with the identified states for future recall.Based on the health index, a range of frequencies may be delivered inresponse. For example, one range may be useful for treating depressionwhile another range may be useful for facilitating sleep. In anembodiment, periodic or continuous monitoring of the baseline state andhealth index may enable fine-tuning the calibration in order tocustomize, individually and temporally, the range of frequenciesdelivered in response.

Another method of calibration to be able to detect stress-relatedtransitions and unwanted stress may be to actively encourage entry intoa particular state (e.g. resting, stressed, fatigued or otheruser-specified states) by delivering a particular stimulation known toprovoke the state then storing the characteristics of the user afterdelivery of the stimulation and entry into the particular state forfuture reference. Confirmation of entry into the state may be done bythe user or via sensor input. In another embodiment, a user may beencouraged to enter a relaxed state, such as by use of a mindfulnessapplication, a meditation application, and/or stimulation, then deliveryof a different stimulation known to provoke a state may be done and theuser characteristics learned and associated with the state. For example,the user may be exposed to stimulation known to provoke increases insympathetic tone and decreases in parasympathetic tone in order toprovoke entry into a stressed state where the device 102 can learn thecharacteristics of that stressed state.

In one method of passive calibration, the user may be exposed to a rangeof stimulation patterns and then sensed parameters are used to determineif the user has reached a target state. After repeated attempts, thebest calming pattern and the best arousing therapy pattern may beselected. In another method of passive calibration, a firsttranscutaneous vibratory output is delivered to a user with parameterscomprising a first perceived pitch, a first perceived beat, and aperceived intensity. The parameters of the first transcutaneousvibratory output may be selected after determining a desired targetstate of a user, such as selected from a database or selected byprediction. After or during delivery of the first transcutaneousvibratory output, data, such as physiologically sensed data or userinput, are used to determine if the user has reached a target state.Modifications may be made to the transcutaneous vibratory output in thecourse of this passive calibration to generate a second transcutaneousvibratory output. Then, the second transcutaneous vibratory output isdelivered to the user with parameters comprising a second perceivedpitch, a second perceived beat, and a perceived intensity, and data areagain used to determine if the user has reached the target state. Basedon the effectiveness of the first and second transcutaneous vibratoryoutputs, a processor may be used to select one of the first or secondtranscutaneous vibratory outputs to be used going forward in assistingthe user to achieve the target state. In embodiments, the processor mayselect neither of the first nor second transcutaneous vibratory outputsin favor of continuing to iteratively modify the transcutaneousvibratory output in order to find a set of transcutaneous vibratoryoutput parameters that are effective in assisting a user in reaching atarget state.

In an embodiment, a plurality of transcutaneous vibratory outputs may beselected based on a desired target state to be used in a calibrationsession. Each of the transcutaneous vibratory outputs may be based onparameters including a perceived pitch, a perceived beat, and aperceived intensity, and may be selected from a database or selected byprediction. During or after emitting each of the plurality oftranscutaneous vibratory outputs in a corresponding session, such aswith an electronic transducer in contact with the portion of the user'sbody, data may be obtained regarding whether a user has achieved thedesired target state in each of the corresponding sessions (e.g. with aphysiological sensor or from user input). Upon determining theeffectiveness of each of the plurality of transcutaneous vibratoryoutputs based on the data, one of the plurality of transcutaneousvibratory outputs may be selected as effective for assisting with entryto the desired target state for the user. The selected transcutaneousvibratory output may then be communicated to a database, the databasecomprising other transcutaneous vibratory outputs determined to beeffective for the desired target state. The database may be accessed toidentify other effective transcutaneous vibratory outputs. One or moreother effective transcutaneous vibratory outputs may be selected fromthe database to be emitted with the electronic transducer. The pluralityof vibratory outputs may be from one user, but in other embodiments, thedatabase may store the vibratory outputs (and those deemed effective fora plurality of users) and thus be used to improve the effectiveness formultiple users.

In personalized passive calibration, periodic measurements may be takenat different time points of the day for a period of time after the userbegins using the device 102. The measurements may be done by one or moresensors, such as physiological sensors, cameras, microphones, or thelike, along with data collected from the user's manual adjustment ofdevice operation. For example, the physiological parameter sensed by thesensors may be movement, heart rate, GSR, temperature, and the like. Theassessments over the course of a period of time, such as the first weekof use, may be used to determine a user's baseline state.

In any of the embodiments described herein, a user's baseline state maybe calculated based on readings from one or more sensors, those sensorsbeing described herein. The baseline state may be determined for a userfor a period of time in a day, such as a morning baseline versus anevening baseline. In some embodiments, in addition to using sensorreadings to establish a baseline state, the user may be prompted toprovide information or ratings about their mood, such as into a userinterface of a mobile device. Mood information may be used to confirm asensor-based establishment of baseline or as another data point in theestablishment of the baseline state. In yet other embodiments, thebaseline state of the user may be additionally based on contextual datareceived from a mobile device of the user. The contextual data may beindicative of an amount of usage of the mobile device. The contextualdata may be keystrokes input into the mobile device. The contextual datamay be indicative of a mood of the user (e.g. negative, positive,frustration, anger, anxiety, distracted, etc.). The contextual data maybe the content of social media posts, wherein the content is used toindicate a mood of the user (e.g. negative, positive, frustration,anger, anxiety, distracted, etc.). In yet still other embodiments,physiological data, user input, facial recognition data, contextualdata, or any combination thereof may be used to establish a baselinestate of a user. In this way, one person's baseline state can bedifferent from another's baseline state.

The system may save baseline state data to a user profile that thesystem may access to set parameters (such as duration and timing,frequency and/or intensity) when applying stimulation to that user inthe future. The system may continue to collect new data as the user usesthe device, and it may supplement the user profile with that data and/orreplace the oldest data with new data as it is received.

Continued measurement with a sensor may be used to determine a deviationfrom the baseline state. Deviation from the baseline state may indicatethat the user is experiencing a stressor. Deviation from the baselinestate may be detected by a change in a sensor reading or a change in agroup of sensor readings. For example, the deviation may be a onestandard deviation shift from the user's baseline. In response, adownstream action may be triggered, such as commencement of therapeuticstimulation, selecting a particular transcutaneous vibratory output todeliver, or triggering a request to commence therapeutic stimulation.

Depending on the magnitude of the deviation from baseline, anappropriate transcutaneous vibratory output given the user's currentstate may be selected. For example, if the user is only experiencing aone standard deviation shift from the user's baseline, thetranscutaneous vibratory output selected may commence at a lowerintensity in order to reach a target state than if the user wasexperiencing a greater shift from baseline. In another example, asmaller shift from baseline may require a shorter duration stimulationthan if the user is far from baseline. Knowing where the baseline is andhow far from baseline the user is currently at, transcutaneous vibratoryoutputs can be dynamically selected to assist the user to reach thetarget state from whatever their current state is. If the user does notreach the target state with the first transcutaneous vibratory outputselected based on the personalized passive calibration, a secondtranscutaneous vibratory output can be selected and generated forapplication to the user in an effort to assist them in reaching thetarget state. Transcutaneous vibratory outputs may also be dynamicallyselected to avoid habituation.

Personalized passive calibration may be embodied in a system comprisingthe stimulation device as described herein, a physiological sensor ofthe stimulation device periodically measuring data of at least onephysiological parameter of the user, and a processor in electroniccommunication with a mobile device and the stimulation device. Referringto FIG. 13, the processor may be programmed to (i) determine a baselinestate of the user based on periodic measurements from the sensor of atleast one physiological parameter of the individual 1320; (ii) determinea deviation from the baseline based on the data of at least onephysiological parameter of the user from the sensor 1322; (iii) based onthe deviation, determine a transcutaneous vibratory output to apply to aportion of the user's body to achieve a target state 1324; and (iv)communicate the determined transcutaneous vibratory output to thestimulation device 1328. Based on the communicated determinedtranscutaneous vibratory output, the transducer of the stimulationdevice generates the transcutaneous vibratory output to be applied to aportion of the user's body, wherein the transcutaneous vibratory outputcomprises a first perceived pitch, a first perceived beat, and a firstperceived intensity. The processor may be further programmed todetermine a baseline state of the user by prompting the user to inputdata of the user's mood into the mobile device or by using contextualdata or combinations thereof, as described herein. In any of theembodiments described herein, the processor may be further programmed todetermine whether the user has achieved the target state (e.g. viasensor or user input), and if the user has not achieved the targetstate, cause the transducer to generate a second transcutaneousvibratory output to be applied to a portion of the user's body to assistthe user in achieving the target state, the second transcutaneousvibratory output comprising a second perceived pitch, a second perceivedbeat, and a second perceived intensity.

Continued collection of baseline data may be stored to form alongitudinal data set. Iterative, real-time tuning and optimization ofthe delivered frequency may be based on the longitudinal data. Forexample, if the user's baseline changes over time, therapeuticstimulation is accurately triggered only when there is a deviation fromthe new baseline. Continuing with this example, as a user progresseswith use of the device 102 and the baseline alters, perhaps to a calmerbaseline state, the therapeutic stimulation protocol used upon adetection of a deviation from baseline may need to be varied in anaspect (e.g. frequency, intensity, and/or duration) in order to affectthe user's state.

As indicated previously, determining an individual user's sensorythreshold may be done via: a) calibration, as described herein; b)active data collection (via brief survey questions in-app); c) passivedata collection (via monitoring mobile device and app usage to determinehow far the user backs down stimulation or how much the user increasesit); and the like. In embodiments, a sensory threshold may be determinedfor a user, such as via a calibration test. The sensory threshold may bemanually adjusted by the user. The intensity of treatment frequenciesmay be delivered within one standard deviation from the sensorythresholds. The lower sensory threshold may be the level at which thevibration is barely noticeable when the user pays attention to it, butit is not distracting and fades into the background when the userattends away. The upper sensory threshold is where the stimulation maybe distracting. Establishing a lower sensory threshold may be done bydelivering a transcutaneous vibratory output to a portion of a user'sbody and gradually reducing an intensity of the transcutaneous vibratoryoutput until the user indicates that it is barely noticeable, such as byusing a user interface of a stimulation device or an applicationcontrolling a stimulation device. Establishing an upper sensorythreshold may be by delivering a transcutaneous vibratory output to aportion of a user's body and gradually increasing an intensity of thetranscutaneous vibratory output until the user indicates that it isdistracting, such as by using a user interface of a stimulation deviceor an application controlling a stimulation device. Alternatively, theuser may establish the lower and upper sensory thresholds themselves bymanually adjusting an intensity of a stimulation until it is barelydetectable on the lower end or distracting on the upper end, wherein thefinal values of the adjustment are stored as the sensory thresholds.

Delivery of stimulation may be configured such that it does not exceed asensory threshold, is at or within one standard deviation from thesensory threshold, or some other point relative to the sensory thresholdsuch that it cannot be felt or is not too distracting or uncomfortable.If the parameters of the stimulation are varied to generate a secondstimulation, as described in various embodiments herein, the secondstimulation may also be configured such that it does not exceed asensory threshold, is at or within one standard deviation from thesensory threshold, or some other point relative to the sensory thresholdsuch that it cannot be felt or is not too distracting or uncomfortable.

Delivery of therapeutic stimulation may take advantage of the sensorythresholds, such as for example to deliver stimulation that tapers. Theintensity of tapered stimulation may start at an upper end of a sensorythreshold and decrease to a barely detectable level over a first period(such as approximately 2 minutes to 15 minutes) at a rate (e.g.approximately 10% per minute). In embodiments, the intensity may remainat the final level for the remaining duration of stimulation (e.g., foranother 15-25 minutes).

After the taper, stimulation may automatically turn off after a periodof time (e.g. after the primary frequency has been applied at its lowestlevel for a period of time. After the taper, stimulation mayautomatically turn off after the total cycle (from starting value tolowest level) has been applied for a period of a period of time (e.g. atleast 30 minutes). The intensity of the stimulus may remain at or within1 standard-deviation of the medians of users' sensory threshold toprovide the desired results.

In some treatment applications involving a stimulation pattern, theperceived pitch may be or start at about 1-200 Hz and the perceived beatmay be between 0.0001-4 Hz, such as for treatment of disorders relatingto hyperarousal such as sleep disorders, chronic pain, post-traumaticstress disorder, chronic stress, autism, autoimmune disorders, anxiety,hypertension, tachycardia, arrhythmias or the like that arecharacterized by increased activity of the sympathetic nervous systemover time. There may also be more than one perceived pitch and more thanone perceived beat.

Treating disorders related to a hyperarousal of the autonomic nervoussystem may include obtaining input of a hyperarousal disorder and asubject's sensory threshold for transcutaneous vibratory output. Theinput of the hyperarousal disorder may be obtained with a user interfacein communication with a processor. Alternatively, input of thehyperarousal disorder may be obtained through sensed data or third partydata. The user's sensory threshold is determined as described herein.Based on the hyperarousal disorder, the processor may select astimulation pattern for transcutaneous vibratory output to be emitted bya transducer of a stimulation device, the stimulation pattern based onparameters comprising a perceived pitch, a perceived beat, and aperceived intensity. The computer processor may cause the transducer togenerate the transcutaneous vibratory output in the selected stimulationpattern at a sensory threshold value at or above the subject's sensorythreshold for transcutaneous vibratory output.

Examples of perceived pitch and perceived beat used to treat certainhyperarousal disorders are provided herein:

Treatment of chronic pain may include the application of a perceivedpitch of about 200 Hz or less and a perceived beat that is equal to orless than about 0.25 Hz, optionally at an intensity within 1.5 standarddeviations of the user's sensory threshold.

Treatment of chronic stress may include the application of a perceivedpitch of 200 Hz or less and a perceived beat that is equal to or lessthan about 4 Hz, optionally at an intensity 1 standard deviation of theuser's sensory threshold.

Treatment of autism may include the application of a perceived pitch ofabout 200 Hz or less and a perceived beat that is equal to or less thanabout 10 Hz, optionally at an intensity within 2 standard deviations ofthe user's sensory threshold.

Treatment of autoimmune disorders may include the application of aperceived pitch of about 200 Hz or less and a perceived beat that isequal to or less than about 10 Hz, optionally at an intensity within 2standard deviations of the user's sensory threshold.

Treatment of anxiety may include the application of a perceived pitch ofabout 200 Hz or less and a perceived beat that is equal to or less than4 Hz, optionally at an intensity within 1 standard deviation of theuser's sensory threshold.

Treatment of hypertension may include the application of a perceivedpitch of about 200 Hz or less and a perceived beat that is equal to orless than 4 Hz, optionally at an intensity within 1 standard deviationof the user's sensory threshold.

In certain other applications, the perceived pitch may be about 40-500Hz and the perceived beat may be about 0.1-20 Hz (e.g., for treatment ofdisorders relating to hypoarousal such as depression, narcolepsy,fatigue, constipation, catatonia, metabolic syndrome, eating disorders,hypotension, attention disorders that are characterized by decreased orunbalanced activity of the sympathetic nervous system over time). Insome embodiments, treatment of disorders relating to hypoarousal may usea perceived pitch of (or starting at) a level that is between 40 Hz to500 Hz, with a perceived beat of 0.1-10 Hz.

Treating disorders related to a hypoarousal of the autonomic nervoussystem may include obtaining input of a hypoarousal disorder and asubject's sensory threshold for transcutaneous vibratory output. Theinput of the hypoarousal disorder may be obtained with a user interfacein communication with a processor. Alternatively, input of thehypoarousal disorder may be obtained through sensed data or third partydata. The user's sensory threshold is determined as described herein.Based on the hypoarousal disorder, the processor may select astimulation pattern for transcutaneous vibratory output to be emitted bya transducer of a stimulation device, the stimulation pattern havingparameters comprising a perceived pitch, a perceived beat, and aperceived intensity. The computer processor may cause the transducer togenerate the transcutaneous vibratory output in the selected stimulationpattern at a sensory threshold value at or above the subject's sensorythreshold for transcutaneous vibratory output.

Examples of perceived pitch and perceived beat used to treat certainhypoarousal disorders are provided herein:

Treatment of depression may include the application of a perceived pitchof about 10 Hz or more and a perceived beat that is equal to or greaterthan about 0.05 Hz, optionally at an intensity within 2 standarddeviations of the user's sensory threshold. In embodiments,anti-depressive pharmaceutical compounds and/or mindfulness activitiesmay be used in conjunction with stimulation to treat depression.

Treatment of fatigue, narcolepsy, excessive daytime somnolence, chronicfatigue syndrome, and the like may include the application of aperceived pitch of 40 Hz or more and a perceived beat that is equal toor greater than about 0.1 Hz, optionally at an intensity within theupper 2 standard deviations of the user's sensory threshold.

Treatment of catatonia may include the application of a perceived pitchof about 10 Hz or more and a perceived beat that is equal to or greaterthan about 0.01 Hz, optionally at an intensity within 1 standarddeviation of the user's sensory threshold.

Treatment of constipation may include the application of a perceivedpitch of about 20 Hz or more and a perceived beat that is equal to orgreater than about 0.05 Hz, optionally at an intensity within the upper2 standard deviations of the user's sensory threshold.

Treatment of attention deficit disorder and other attention andconcentration issues may include the application of a perceived pitch ofabout 40 Hz or more and a perceived beat that is equal to or greaterthan about 0.1 Hz, optionally at an intensity within 1 standarddeviation of the user's sensory threshold.

Treatment of disorders of metabolism including insulin insensitivity(i.e. type 2 diabetes mellitus) and metabolic syndrome may include theapplication of a perceived pitch of about 10 Hz or more and a perceivedbeat that is equal to or greater than 0.001 Hz, optionally at anintensity within 2 standard deviations of the user's sensory threshold.

Treatment of hypotension and dysautonomia may include the application ofa perceived pitch of about 20 Hz or more and a perceived beat that isequal to or greater than 0.001 Hz, optionally at an intensity within theupper 2 standard deviations of the user's sensory threshold.

To decrease symptoms of hyperarousal disorders, these layeredoscillations may start at a higher frequency that corresponds to acurrent energy level of the user, and taper down to slower oscillationsthat correspond to an upper threshold level of energy associated withdeep relaxation and/or somnolence (the goal state in this case). Forexample, the perceived pitch may start at a starting value (such as 100Hz) that is established by any suitable means, such as by being adefault, or based on a user-selectable input, or based on the user'sresponse to certain questions such as “how do you feel,” or based ondata collected from the user's mobile electronic device and/or awearable device having sensors such as accelerometers. Different inputsmay be associated with different starting values, such as by a lookuptable, or by an algorithm that considers combinations of input details.In general, for sleep applications, in some embodiments the startingvalue of the perceived pitch would not be greater than 200 Hz.

In one embodiment, the perceived pitch could then decrease from thestarting value (e.g. 200 Hz) at a rate of approximately 5-10 Hz every10-20 seconds (approximately) until it reaches an upper threshold (suchas approximately 40 Hz) level. The perceived pitch may remain at theupper threshold for a holding period (stabilization phase), such asapproximately 60 seconds. The perceived pitch may then decrease at arate of approximately 1 Hz every 10 seconds (approximately) until itreaches a second threshold (stabilization phase) that is less than thefirst threshold (such as approximately 30 Hz, or approximately 75% ofthe first threshold). The perceived pitch may remain at the secondthreshold for the holding period. After that, the perceived pitch maydecrease at a rate of approximately 1 Hz every 10 seconds(approximately) until it reaches a third threshold that is lower thanthe second threshold (such as 20 Hz, or approximately 50% of the upperthreshold) and remain at 20 Hz for an effective period (such asapproximately 20 minutes). This effective period may be determined inpart by the software time limits (minimum: 5 minutes/maximum: 60minutes) and/or in part by the user.

During this process, the perceived beat may start at a first level (suchas 0.2 Hz) and decrease by a rate of approximately 0.025 Hz every 15seconds until it reaches approximately 0.1 Hz. The perceived beat mayremain at approximately 0.1 Hz for approximately 120 seconds. Theperceived beat may then decrease by approximately 0.01 Hz every 30seconds until it reaches the desired frequency to achieve desiredresults (e.g., approximately 0.05 Hz). The perceived beat may remain at0.05 Hz for the effective period (such as up to 20 minutes) or until theperceived pitch changes.

By way of examples, a perceived pitch starting at approximately 100 Hzmay be available as an option with the longest/slowest taper (e.g., a60-minute cycle), approximately 40 Hz may be considered to be an averagestarting point for the perceived pitch (e.g., a 30-minute cycle), andapproximately 33 Hz may be considered to be the perceived pitch'sstarting point for the shortest/fastest taper (e.g., a 10-minute cycle).Similarly, the perceived pitch and the perceived beat may also taperindependently or in tandem. One iteration of this for rapid relaxationcould have the perceived pitch starting at 200 Hz and tapering to 40 Hzover the course of 5 minutes and then stabilizing at 40 Hz for another10 minutes, while the perceived beat starts at 2 Hz and tapers to 0.1 Hzgradually over 15 minutes. In each case, the value of the difference maytaper over time so that the primary and secondary oscillations are veryclose together, such as a difference of approximately 0.0001 Hz, beforeeach frequency reaches zero. Optionally, the perceived beat's tapers mayhave a longer period than the perceived pitch's taper because they maytake the user through more arousal states prior to finally arriving atthe desired effect, especially if the user was more symptomatic prior tousing the device. In general, for each frequency, the greater the speedof the taper (the less time spent in each frequency state), the quickerthe user is likely to transition from symptomatic to asymptomatic.Specific combinations may include, for example: (A) a perceived pitchstarting at approximately 100 Hz and tapering down to 20 Hz untilshut-off, with a perceived beat that initially differs from the primaryby approximately 1 Hz, with the difference tapering down to 0.01 Hz overtime; (B) a perceived pitch starting at approximately 40 Hz and taperingdown to 10 Hz until shut-off, with a perceived beat that initiallydiffers from the primary by approximately 0.2 Hz, with the differencetapering down to 0.001 Hz over time until shut-off; and (C) a perceivedpitch starting at approximately 33 Hz and tapering down to 1 Hz untilshut-off, with a perceived beat that initially differs from the primaryby approximately 0.1 Hz, with the difference tapering down to 0.0001 Hzover time until shut-off.

Similarly, in some applications that take advantage of the alternativeembodiment of layering sine waves to produce an interference pattern,the primary frequency may be about 1-200 Hz and the modulation frequencymay be about 0.0001-4 Hz different from the primary frequency (e.g., fortreatment of disorders relating to hyperarousal such as sleep disorders,chronic pain, post-traumatic stress disorder, chronic stress, autism,autoimmune disorders, anxiety, hypertension, or the like that arecharacterized by increased activity of the sympathetic nervous systemover time). In some embodiments, the perceived beat is generated in partby a primary frequency of (or starting at) a level that is from 10 to200 Hz, with a secondary frequency that differs from the primaryfrequency by 0.0001 or more.

Examples may include, without limitation:

Treatment of chronic pain may include the application of a mainfrequency of about 100 Hz or less and a modulation frequency that isequal to or less than about 0.2 Hz different from the primary frequency,optionally at an intensity within 1 standard deviation of the medians ofuser's sensory threshold.

Treatment of chronic stress may include the application of a mainfrequency of 200 Hz or less and a modulation frequency that is equal toor less than about 4 Hz different from the primary frequency, optionallyat an intensity 1 standard deviation of the medians of user's sensorythreshold.

Treatment of autism may include the application of a main frequency ofabout 200 Hz or less and a modulation frequency that is equal to or lessthan about 4 Hz different from the primary frequency, optionally at anintensity within 2 standard deviations of the medians of user's sensorythreshold.

Treatment of autoimmune disorders may include the application of a mainfrequency of about 200 Hz or less and a modulation frequency that isequal to or less than about 1 Hz different from the primary frequency,optionally at an intensity within 1 standard deviation of the medians ofthe user's sensory threshold.

Treatment of anxiety may include the application of a main frequency ofabout 200 Hz or less and a modulation frequency that is equal to or lessthan 4 Hz different from the primary frequency, optionally at anintensity within 1 standard deviation of the medians of user's sensorythreshold.

Treatment of hypertension may include the application of a mainfrequency of about 100 Hz or less and a modulation frequency that isequal to or less than 4 Hz different from the primary frequency,optionally at an intensity within 1 standard deviation of the medians ofuser's sensory threshold.

In certain other applications, the main frequency may be about 40-500 Hzand the modulation frequency may be about 0.1-10 Hz different from theprimary frequency (e.g., for treatment of disorders relating tohypoarousal such as depression, narcolepsy, fatigue, constipation,catatonia, metabolic syndrome, eating disorders, hypotension, attentiondisorders that are characterized by decreased or unbalanced activity ofthe sympathetic nervous system over time). In some embodiments,treatment of disorders relating to hypoarousal may use a primaryfrequency of (or starting at) a level that is between 40 Hz to 200 Hz,with a secondary frequency that differs from the primary frequency by0.1-10 Hz. The perceived beat of the stimulation is generated in part bythe difference in the primary and secondary frequency.

Continuing with examples, the examples may include, without limitation:

Treatment of depression may include the application of a main frequencyof about 40 Hz or more and a modulation frequency that is equal to orgreater than about 0.1 Hz-4 Hz different from the primary frequency,optionally at an intensity within the upper 2 standard deviations of themedians of user's sensory threshold.

Treatment of fatigue, narcolepsy, excessive daytime somnolence, chronicfatigue syndrome, and the like may include the application of a mainfrequency of 89 Hz or more and a modulation frequency that is equal toor greater than about 0.1 Hz different from the primary frequency,optionally at an intensity within the upper 2 standard deviations of themedians user's sensory threshold.

Treatment of catatonia may include the application of a main frequencyof about 10 Hz or more and a modulation frequency that is equal to orgreater than about 0.1 Hz different from the primary frequency,optionally at an intensity within 1 standard deviation of the medians ofuser's sensory threshold.

Treatment of constipation may include the application of a mainfrequency of about 20 Hz or more and a modulation frequency that isequal to or greater than about 0.1 Hz different from the primaryfrequency, optionally at an intensity within the upper 2 standarddeviations of the medians of user's sensory threshold.

Treatment of attention deficit disorder and other attention andconcentration issues may include the application of a main frequency ofabout 40 Hz or more and a modulation frequency that is equal to orgreater than about 0.1 Hz different from the primary frequency,optionally at an intensity within 1 standard deviation of the medians ofuser's sensory threshold.

Treatment of disorders of metabolism including insulin insensitivity(type 2 diabetes mellitus) and metabolic syndrome may include theapplication of a main frequency of about 40 Hz or more and a modulationfrequency that is equal to or greater than 0.1 Hz different from theprimary frequency, optionally at an intensity within 2 standarddeviations of the medians of user's sensory threshold.

Treatment of hypotension and dysautonomia may include the application ofa main frequency of about 60 Hz or more and a modulation frequency thatis equal to or greater than 0.1 Hz different from the primary frequency,optionally at an intensity within the upper 2 standard deviations of themedians of user's sensory threshold.

To decrease symptoms of hyperarousal disorders, the oscillations maystart at a higher frequency that corresponds to a current energy levelof the user, and taper to a frequency that corresponds to an upperthreshold level of energy associated with deep relaxation and/orsomnolence. For example, the primary frequency may start at a startingvalue (such as 100 Hz) that is established by any suitable means, suchas by being a default, or based on a user-selectable input, or based onthe user's response to certain questions such as “how do you feel,” orbased on data collected from the user's mobile electronic device and/ora wearable device having sensors such as accelerometers. Differentinputs may be associated with different starting values, such as by alookup table, or by an algorithm that considers combinations of inputdetails. In general, for sleep applications, in some embodiments thestarting value of the primary frequency would not be greater than 100Hz.

The primary frequency may then decrease from the starting value at arate of approximately 5-10 Hz every 20 seconds (approximately) until itreaches the upper threshold level (such as approximately 40 Hz). Theprimary frequency may remain the upper threshold for a holding period,such as approximately 60 seconds. The primary frequency may thendecrease at a rate of approximately 1 Hz every 10 seconds(approximately) until it reaches a second threshold that is less thanthe first threshold (such as approximately 30 Hz, or approximately 75%of the first threshold). The primary frequency may remain at the secondthreshold for the holding period. After that, the primary frequency maydecrease at a rate of approximately 1 Hz every 10 seconds(approximately) until it reaches a third threshold that is lower thanthe second threshold (such as 20 Hz, or approximately 50% of the upperthreshold) and remain at 20 Hz for an effective period (such asapproximately 20 minutes). This effective period may be determined inpart by the software time limits (minimum: 5 minutes/maximum: 60minutes) and/or in part by the user.

During this process, the secondary frequency may start at a first level(such as 0.2 Hz) and decrease by a rate of approximately 0.025 Hz every15 seconds until it reaches approximately 0.1 Hz. The secondaryfrequency may remain at approximately 0.1 Hz for approximately 120seconds. The secondary frequency may then decrease by approximately 0.01Hz every 30 seconds until it reaches the desired frequency to relievesymptoms (e.g., approximately 0.05 Hz). The secondary frequency mayremain at 0.01 Hz for the effective period (such as up to 20 minutes) oruntil the primary frequency changes.

By way of examples, a primary frequency starting at approximately 100 Hzmay be available as an option with the longest/slowest taper (e.g., a60-minute cycle), approximately 40 Hz may be considered to be an averagestarting point for the primary frequency (e.g., a 30-minute cycle), andapproximately 33 Hz may be considered to be the primary frequency'sstarting point for the shortest/fastest taper (e.g., a 10-minute cycle).Similarly, the difference between the primary frequency and thesecondary frequency (i.e., the modulation frequency) may also taper,such as starting at a difference from the primary frequency ofapproximately >2 Hz=longest taper; starting at a difference ofapproximately 0.2-2 Hz=moderate taper; and starting at a difference ofapproximately <0.2 Hz=shortest taper. In each case, the value of thedifference may taper over time so that the primary and secondaryoscillations are very close together, such as a difference ofapproximately 0.0001 Hz, before each frequency reaches zero. Optionally,the secondary frequency's tapers may have a longer period than theprimary frequency's taper because they may take the user through morearousal states prior to finally arriving at the desired effect,especially if the user was more symptomatic prior to using the device.In general, for each frequency, the greater the speed of the taper (theless time spent in each frequency state), the quicker the user is likelyto transition from symptomatic to asymptomatic. Specific combinationsmay include, for example: (A) a primary frequency starting atapproximately 100 Hz and tapering down to 20 Hz until shut-off, with asecondary frequency that initially differs from the primary byapproximately 1 Hz, with the difference tapering down to 0.01 Hz overtime; (B) a primary frequency starting at approximately 40 Hz andtapering down to 10 Hz until shut-off, with a secondary frequency thatinitially differs from the primary by approximately 0.2 Hz, with thedifference tapering down to 0.001 Hz over time until shut-off; and (C) aprimary frequency starting at approximately 33 Hz and tapering down to 1Hz until shut-off, with a secondary frequency that initially differsfrom the primary by approximately 0.1 Hz, with the difference taperingdown to 0.0001 Hz over time until shut-off.

Similarly, to decrease symptoms of hypoarousal disorders, theoscillations may start at a lower frequency that corresponds to acurrent energy level of the user, and increase to a frequency thatcorresponds to a threshold level of energy associated with energizing auser. For example, the primary frequency may start at a starting value(such as 40 Hz) that is established by any suitable means, such as bybeing a default, or based on a user-selectable input, or based on theuser's response to certain questions such as “how do you feel,” or basedon data collected from the user's mobile electronic device and/or awearable device having sensors such as accelerometers. Different inputsmay be associated with different starting values, such as by a lookuptable, or by an algorithm that considers combinations of input details.

The primary frequency may then increase from the starting value at arate of approximately 5-10 Hz every 20 seconds (approximately) until itreaches the upper threshold level (such as approximately 40 Hz). Theprimary frequency may remain at the upper threshold for a holdingperiod, such as approximately 60 seconds. The primary frequency may thenincrease at a rate of approximately 1 Hz every 10 seconds(approximately) until it reaches a second threshold that is greater thanthe first threshold (such as approximately 600 Hz). The primaryfrequency may remain at the second threshold for the holding period.After that, the primary frequency may increase at a rate ofapproximately 1 Hz every 10 seconds (approximately) until it reaches athird threshold that is higher than the second threshold (such as 100Hz) and remain at 100 Hz for an effective period (such as approximately20 minutes). This effective period may be determined in part by thesoftware time limits (minimum: 5 minutes/maximum: 60 minutes) and/or inpart by the user.

During this process, the secondary frequency may start at a first level(such as 0.2 Hz) and increase by a rate of approximately 0.025 Hz every15 seconds until it reaches approximately 1 Hz. The secondary frequencymay remain at approximately 1 Hz for approximately 120 seconds. Thesecondary frequency may then decrease by approximately 0.01 Hz every 30seconds until it reaches the desired frequency to relieve symptoms(e.g., approximately 5 Hz). The secondary frequency may remain at 5 Hzfor the effective period (such as up to 20 minutes) or until the primaryfrequency changes.

The stimulation works by increasing the balance between the sympatheticand parasympathetic components of the autonomic nervous system, which isrequired for optimal functioning of the human body. One way in which thestimulation device 102 may deliver treatment therapy is by acousticand/or vibration induced stimulation to increase parasympatheticactivity, inhibit sympathetic activity, increase sympathetic activity,and/or inhibit parasympathetic activity, collectively referred to asmodulation of the autonomic nervous system. The above frequency rangesare provided for example purposes only and may be adjusted or tuned fora subject based on the subject's physiological reactions using afeedback loop, as described below. Specifically, the above frequenciesmay be personalized to a subject based on biometric data collected bythe sensor device 118 (e.g., heart rate, heart rate variability, bloodpressure, respirations, sweat level, resting pulse rate, brain activity,etc.) and/or based on user feedback.

In general, the increase in parasympathetic and sympathetic nervoussystem balance that results from the application of low frequency sound(or vibration) is perceptible and can be monitored in real time, therebypermitting careful monitoring of the result, and modulation, control orwithdrawal of the stimulation as necessary. In certain embodiments, theresults may be presented to a subject by, for example, the userinterface and/or via an application on a user device. Furthermore, atreatment plan may be designed in which either continuous or pulseddelivery of low frequency sound is carried out over a period of days,weeks, months, or even years, depending on the particular circumstancesof the subject being treated.

Therapeutic stimulation may facilitate entry into a sleep state. Mostpeople experience difficulty falling asleep and/or staying asleep atsome point in their lives. Sleeplessness may occur in reaction tostressful events in a person's life, during travel when normal bodyrhythms are disrupted, in response to the person engaging in stimulatingactivities before bedtime, or for other reasons. Many people repeatedlyexperience sleeplessness over multiple nights during a week, and such acondition may be considered to be acute insomnia. If this patterncontinues over multiple months, it may be considered to be chronicinsomnia.

It has been estimated that 25 to 30 percent of humans experience acuteinsomnia each year. Because of this, many treatments are offered to helptreat insomnia. These treatments range from pharmaceutical treatmentssuch as benzodiazepine and non-benzodiazepine sedatives as well asnatural interventions. Many pharmaceutical treatments can cause unwantedside effects, must be monitored for interaction with other drugs, andcan cause sleepiness to continue past the person's desired sleep time.Non-pharmaceutical treatments, such as bright light therapy andcognitive behavioral therapy, can be time-consuming and require asignificant amount of self-discipline by the person to continue thecourse of therapy. Accordingly, better ways of treating insomnia andother forms of sleeplessness are desired.

This disclosure provides a method and system for treating sleeplessnessby applying and removing vibratory or sonic stimulation to the humanbody in a pattern that increases balance between the sympathetic andparasympathetic components of the autonomic nervous system. Thestimulation may improve parasympathetic nervous system activity, therebybalancing activity in the autonomic nervous system, by activatingafferent sensory nerve fibers in the skin and deep tissue that networkwith the parasympathetic nervous system in the spinal cord and brain, toinclude the Vagus nerve and its collaterals as a primary component. Thisimprovement in parasympathetic activity results in a reduction ofaberrant or unwanted activity in the sympathetic nervous systemactivity.

Terminology that is relevant to this disclosure includes the term“sleeplessness”. Sleeplessness includes general physical conditions inwhich a person exhibits an inability to fall asleep and/or to remainasleep for more than a brief period of time (such as only one to threehours). “Insomnia” refers to a condition in which a person experiencessleeplessness multiple nights per week. Chronic insomnia is insomniathat occurs at least three nights per week and lasts at least threemonths. Insomnia that persists for a lesser period of time may beconsidered to be acute insomnia.

To induce deep relaxation and/or somnolence leading to sleep in asubject who is awake, the transcutaneous vibratory output may start at ahigher frequency/pitch/beat/intensity that corresponds to a currentenergy level of the user, and taper to a frequency/pitch/beat/intensitythat corresponds to an upper threshold level of energy associated withdeep relaxation and/or somnolence. For example, the primary frequency orperceived pitch may start at a starting value that is established by anysuitable means, such as by being a default, based on a user-selectableinput, based on the user's response to certain questions such as “how doyou feel,” or based on data collected from the user's mobile electronicdevice and/or a wearable device having sensors such as accelerometers.Different inputs may be associated with different starting values, suchas by a lookup table, or by an algorithm that considers combinations ofinput details.

In some embodiments, transcutaneous vibratory output may be caused tocommence automatically, such as at a certain time or in response to asensor worn by or in proximity to the user providing data to a processorindicating that they are in a pre-sleep state. For example, anaccelerometer may indicate slowing or no motion indicating a readinessfor sleep.

Referring to FIG. 14, upon receiving the data 1402, the processor mayprovide to a transducer a stimulation pattern 1404 for transcutaneousvibratory output to be emitted by the transducer. The stimulationpattern may have parameters comprising a perceived pitch, a perceivedbeat, and a perceived intensity. In some embodiments, the stimulationpattern may comprise a perceived pitch between 1-100 Hz and a perceivedbeat at a second frequency between 0.0001 and 1.5 Hz. In otherembodiments, the perceived beat is generated in part by a firstoscillation at a first frequency that is in the range of 1-100 Hz, and asecond oscillation at a second frequency that differs from the firstfrequency by 0.0001 to 1.5 Hz. The sensors may continue to collect data1408 to determine a sleep state of the user (e.g. pre-sleep, almostasleep, asleep). Based on the sleep state as determined by the sensors,the processor may alter 1410 the stimulation pattern, such as tocommence a taper 1412, accelerate a taper 1414, discontinue thestimulation pattern 1418 or power down the device 1420 when the user isasleep, extend the duration of the stimulation pattern 1422, or thelike. Altering the stimulation pattern may also include at least one of(i) reducing a frequency of the perceived pitch 1424, (ii) increasing aninterval of the perceived beat 1428, or (iii) reducing the intensity1430. In some embodiments, the stimulation pattern may be matched to thesleep state. For example, if the accelerometers indicate a slowing inactivity but other indicators suggest the user is ready for sleep butnot asleep yet, particular relaxing frequencies may begin to be emittedto ease the eventual transition to sleep.

When a frequency of the perceived pitch is reduced to a first reducedperceived pitch, the first reduced perceived pitch may be maintained fora selected period of time or until sensors indicate a change in theuser's sleep state that may require another alteration in thestimulation pattern. For example, if the sensor indicates that the userhas reached the almost asleep state, a second alteration of thestimulation pattern may be triggered and the first reduced perceivedpitch may be reduced to a second reduced perceived pitch which may bemaintained for a selected period of time or until sensors indicate achange in the user's sleep state that may require another alteration inthe stimulation pattern. For example, during sleep, an accelerometer maysense motion during a bad dream and a stimulation pattern may betriggered to encourage re-entry into a sleep state.

When an interval of the perceived beat is reduced to a first increasedperceived beat, the first reduced perceived beat may be maintained for aselected period of time or until sensors indicate a change in the user'ssleep state that may require another alteration in the stimulationpattern. For example, if the sensor indicates that the user has reachedthe almost asleep state, a second alteration of the stimulation patternmay be triggered and the first reduced perceived beat may be reduced toa second reduced perceived beat which may be maintained for a selectedperiod of time or until sensors indicate a change in the user's sleepstate that may require another alteration in the stimulation pattern.

When an intensity is reduced to a first reduced intensity, the firstreduced intensity may be maintained for a selected period of time oruntil sensors indicate a change in the user's sleep state that mayrequire another alteration in the stimulation pattern. For example, ifthe sensor indicates that the user has reached the almost asleep state,a second alteration of the stimulation pattern may be triggered and thefirst reduced intensity may be reduced to a second reduced intensitywhich may be maintained for a selected period of time or until sensorsindicate a change in the user's sleep state that may require anotheralteration in the stimulation pattern.

For example, a perceived pitch starting at approximately 100 Hz may beavailable as an option with the longest/slowest taper (e.g., a 30-minutecycle), approximately 40 Hz may be considered to be an average startingpoint for the perceived pitch (e.g., a 20-minute cycle), andapproximately 30 Hz or approximately 33 Hz may be considered to be theperceived pitch's starting point for the shortest/fastest taper (e.g., a10-minute cycle). Similarly, the perceived beat may also taperindependently of the perceived pitch, such as starting at approximately0.2-1 Hz for the longest taper; starting at approximately 0.1-0.2 Hz fora moderate taper; and starting at 0.05-0.1 Hz for the shortest taper. Ineach case, the frequency of the perceived pitch and/or perceived beatmay taper over time. Optionally, the perceived beat's tapers may have alonger period than that of the perceived pitch because they may take theuser through more arousal states prior to finally arriving at sleep,especially if the user was more energized/awake prior to using thedevice. In general, for each frequency, the greater the speed of thetaper (the less time spent in each frequency state), the quicker theuser is likely to transition from awake to sleep. Specific combinationsmay include, for example: (A) a perceived pitch starting atapproximately 100 Hz and tapering down to 1 Hz until shut-off, with aperceived beat starts at 1 Hz tapering down to 0.0001 Hz over time; (B)a perceived pitch starting at approximately 40 Hz and tapering down to 1Hz until shut-off, with a perceived beat starting at approximately 0.2Hz tapering down to 0.0001 Hz over time until shut-off; and (C) aperceived pitch starting at approximately 33 Hz and tapering down to 1Hz until shut-off, with a perceived beat of approximately 0.1 Hztapering down to 0.0001 Hz over time until shut-off.

In the alternative embodiment of layered sine waves generating aninterference pattern, the primary frequency may decrease from a startingvalue, such as 100 Hz, until it reaches the upper threshold level (suchas approximately 40 Hz). The rate at which the stimulation is taperedmay be programmed. For example, the tapering rate may be a rate ofapproximately 5-10 Hz every 20 seconds. The primary frequency may remainat the upper threshold for a holding period, such as approximately 60seconds. The primary frequency may then decrease (e.g. at a rate ofapproximately 1 Hz every 10 seconds) until it reaches a second thresholdthat is less than the first threshold (such as approximately 30 Hz, orapproximately 75% of the first threshold). The primary frequency mayremain at the second threshold for the holding period. After that, theprimary frequency may decrease (e.g. at a rate of approximately 1 Hzevery 10 seconds) until it reaches a third threshold that is lower thanthe second threshold (such as 10 Hz, or approximately 25% of the upperthreshold) and remain at the third threshold for a sleep period (such asapproximately 20 minutes).

Continuing with the embodiment of layered sine waves generating aninterference pattern, during this process, a secondary frequency maystart at a first level (such as 0.2 Hz) and decrease (e.g. by a rate ofapproximately 0.025 Hz every 15 seconds) until it reaches a secondlevel, such as approximately 0.1 Hz in this example. The secondaryfrequency may remain at the second level for a duration (e.g.approximately 240 seconds). The secondary frequency may then decrease(e.g. such as at a rate of approximately 0.01 Hz every 30 seconds) untilit reaches the desired frequency for sleep (e.g., approximately 0.01Hz). The secondary frequency may remain at the desired frequency for thesleep period (such as up to 20 minutes) or until the primary frequencychanges.

By way of example, and continuing with the embodiment of layered sinewaves generating an interference pattern, a primary frequency startingat approximately 100 Hz may be available as an option with thelongest/slowest taper (e.g., a 30-minute cycle), approximately 40 Hz maybe considered to be an average starting point for the primary frequency(e.g., a 20-minute cycle), and approximately 30 Hz or approximately 33Hz may be considered to be the primary frequency's starting point forthe shortest/fastest taper (e.g., a 10-minute cycle). Similarly, thedifference between the primary frequency and the secondary frequency(i.e., the modulation frequency) may also taper, such as starting at adifference from the primary frequency of approximately 0.2-1 Hz for thelongest taper; starting at a difference of approximately 0.1-0.2 Hz fora moderate taper; and starting at a difference of approximately 0.05 Hzfor the shortest taper. In each case, the value of the difference maytaper over time so that the primary and secondary oscillations may bevery close together, such as a difference of approximately 0.0001 Hz,before each frequency reaches zero. Optionally, the secondaryfrequency's tapers may have a longer period than the primary frequency'staper because they may take the user through more arousal states priorto finally arriving at sleep, especially if the user was moreenergized/awake prior to using the device. In general, for eachfrequency, the greater the speed of the taper (the less time spent ineach frequency state), the quicker the user is likely to transition fromawake to sleep. Specific combinations may include, for example: (A) aprimary frequency starting at approximately 100 Hz and tapering down to1 until shut-off, with a secondary frequency that initially differs fromthe primary by approximately 1 Hz, with the difference tapering down to0.0001 Hz over time; (B) a primary frequency starting at approximately40 Hz and tapering down to 1 until shut-off, with a secondary frequencythat initially differs from the primary by approximately 0.2 Hz, withthe difference tapering down to 0.0001 Hz over time until shut-off; and(C) a primary frequency starting at approximately 33 Hz and taperingdown to 1 until shut-off, with a secondary frequency that initiallydiffers from the primary by approximately 0.1 Hz, with the differencetapering down to 0.0001 Hz over time until shut-off. In embodiments, thefirst oscillation of two or more oscillations may exhibit a firstfrequency having a starting value that is in the range of approximately1 to approximately 100 Hz, and a second oscillation of two or moreoscillations may exhibit a second frequency initially differs from thefirst frequency by approximately 0.0001 to approximately 1 Hz. The twoor more oscillations collectively form a beat output.

In some embodiments, the user interface of the system may include aninput field in which a user can select modes that will increase ordecrease the speed by which the frequencies taper from the upperstarting point to the lower ending point. For example, a user who wantsto fall asleep very quickly may select a mode in which the frequenciestaper on the more rapid end of the spectrum, while those who are windingdown (de-escalating) more slowly or who are more highly energized beforebed may choose to have a frequency taper on the more delayed end of thespectrum. The user may make this selection by a slider or dial, byentering numeric values, or by selecting from one of various modes (inwhich each mode will have various times and thresholds assigned to it).

In some embodiments, as the frequency of the vibration tapers down, theintensity of the vibration is also tapered from a more intense value toa less intense value or the opposite. That is to say that eachfrequency, the perceived pitch, the perceived beat, and the perceivedintensity can be modulated independently of one another. The device maydo this by decreasing the current applied to the transducer's coil asthe device also reduces the sonic emissions' frequencies. The intensityof the oscillations may start at the upper end of a sensory threshold(at which the user would have a harder time ignoring the vibration). Theintensity may then decrease to a barely detectable level (at the bottomend of the sensory threshold) over a first period (such as approximately15 minutes) at a rate (e.g. approximately 10% per minute). The rate maybe measured from the level that existed during the previous minute. Theintensity may remain at the final level for the remaining duration ofstimulation (e.g., for another 15-25 minutes). Shorter time periods maybe used if fewer thresholds are used. In other embodiments, theintensity of the stimulus may remain at or within 1 standard-deviationof the medians of users' sensory threshold to provide the desiredresults.

The stimulation may automatically turn off after a period of time, suchas after the primary frequency has been applied at its lowest level, orafter the total cycle (from starting value to lowest level) has beenapplied for a period (e.g. at least 30 minutes). Other time values maybe used to trigger the automatic shut-off. The sonic vibration mayremain on for a longer period associated with a desired rest ortreatment period (such as 6 hours, 7 hours or 8 hours), or can continueuntil the user wakes up and turns the vibration off. Optionally, thesystem may default to shutting off after an initial cycle (such as 20-30minutes) unless a sensor device that is in communication with thestimulation device 102 or its controller provides data showing that theuser is not yet reached a desired measurable biometric state (such as atarget breathing rate, heart rate, pulse, movement, etc.). Such data mayinclude data from a body movement sensor worn by the user indicatingthat the user is moving or has moved more than a threshold level duringa specified period of time just before the end of the sleep cycle (e.g.,1 minute before the end of the sleep cycle, 3 minutes before the end ofthe sleep cycle, etc.). The body movement sensor may also indicate thatthe user is no longer moving, which may be an indication that the userhas fallen asleep, and the stimulation may be discontinued, tapered downat a faster rate, or switched immediately to a level for sleepmaintenance.

Optionally, the sonic vibrations may be initiated within 1 hour beforethe user desires to fall asleep. However, the stimulation may begin toinduce states of relaxation and somnolence in as little as threeminutes. The stimulation may be effective when the primary frequency'sis applied in combination with the modulation frequency for a duration,such as at least 15 minutes. In some embodiments, a sleep mode may applythe stimulation for a pre-determined duration (e.g. 30-40 minutes). Thesystem may enable the user to select the duration of the program in someembodiments.

In an aspect, a method of delivering and tapering a user stimulation mayinclude tapering a first oscillation (also known as main frequency orbase tone) down from an upper threshold frequency to a lower thresholdfrequency over a first period of time, and maintaining the firstoscillation/base tone at the lower threshold frequency during a secondperiod of time (e.g. 5 min). Tapering may utilize a first tapering rateto taper the first oscillation/base tone down to a target frequency(e.g. 100 Hz, 40 Hz, 33 Hz, 30 Hz, 1 Hz, or the like), and when thefirst oscillation/base tone reaches the target frequency changing thetapering rate to a second tapering rate when tapering the firstoscillation/base tone from the target frequency to the lower thresholdfrequency (e.g. 40 Hz, 33 Hz, 30 Hz, 1 Hz, or the like). In embodiments,the first oscillation/base tone target frequency may be any frequency,such as a frequency chosen from 0.1 Hz to 100 Hz (e.g. 100 Hz, 40 Hz, 33Hz, 30 Hz, 1 Hz, or the like). The stimulation device 102 may emit abeat output as vibrations that correspond to the therapeutic stimulationpattern which may include starting the second oscillation (also known asmodulation frequency or perceived beat frequency) at a first thresholdfrequency, tapering the second oscillation down to a second thresholdfrequency over the first period of time, and maintaining the secondoscillation at the second threshold frequency during the second periodof time. The tapering rate may be user-customizable and adjustable. Theupper threshold frequency may be user-set based on a current activity, acurrent user-indicated feeling, a desired feeling, a lookup table, or byan algorithm that considers combinations of input details.

In an embodiment, the duration of the taper cycle may vary with thestarting oscillation. For example, the taper cycle may be 30 min, 20min, 10 min, or the like. In an embodiment, the modulation frequency mayalso be tapered, such as described herein with respect to the primaryfrequency. For example, the modulation frequency or the perceived beatmay start at approximately 1 Hz for the longest taper; at approximately0.1-0.2 Hz for a moderate taper; or at approximately 0.05 Hz for theshortest taper.

In an embodiment, the value of the difference between main andmodulation frequency may be tapered over time so that they are veryclose together before each frequency reaches zero. In some embodiments,the secondary, or modulation, frequency's tapers may have a longerperiod than the primary frequency's taper. In an embodiment, a shut-offmay be triggered after a specific period of time or after the primaryfrequency has been applied at its lowest level for a period of time.

In an embodiment, based on a desired target state of a user, a firsttranscutaneous vibratory output comprising parameters including a firstperceived pitch, a first perceived beat, and a first perceived intensityis generated for application to a body portion of a user. A value of oneor more of the first perceived pitch, the first perceived beat, and thefirst perceived intensity begins at an upper value, and depending on thestimulation protocol needed to reach the desired target state, the firsttranscutaneous vibratory output may be tapered by tapering the one ormore of the first perceived pitch, the first perceived beat, and thefirst perceived intensity down to a lower value over a first period oftime. The lower value may be maintained during a second period of time.A first tapering rate may be used to taper the first perceived pitch orthe first perceived beat down to a target frequency before the lowervalue. After reaching the target frequency, tapering or the stimulationmay be discontinued, such as if sensors indicate a target state hasalready been reached, or a second tapering rate may be used to taperfrom the target frequency to a lower value. As many segments of taperingto incrementally lower values at the same or a different tapering ratemay be used in order to reach the lower value.

In embodiments, the therapeutic stimulation may increase from a startingvalue and ramp up to a target value. For example, one or more of theperceived pitch, perceived beat frequency, or intensity may be ramped upfrom a starting value to a target value. The starting value may be alower threshold frequency. The target value may be selected tocorrespond with a therapeutic goal, may be an upper threshold frequency,or the like. Ramping up may be done via a rate over a period of time,wherein the rate itself may be variable or ramped in speed. As manysegments of ramping up to incrementally higher values at the same or adifferent ramping rate may be used in order to reach the highest value.In embodiments, once the target value is reached, it may be maintainedfor a second period of time or until it is caused to be terminated ortapered down, such as in response to sensor feedback or via a manualinput.

In an embodiment, the system may be able to predict the onset of a statefor a user, such as an emotional state. Various emotional states includeanger, fear, annoyance, sadness, anxiety, apathy, frustration,distracted, or the like. Predicting the onset of the state may cause thesystem to address the user's current state or avoid the predicted state.Addressing or avoiding may involve a stimulation protocol beingtriggered, such as a stimulation directed at mitigating the onset of thestate or treating the state. The user's predicted state may bedetermined by electronically sensing at least one of a physiologicalstate of the user or a contextual data of the user. In some embodiments,the predicted state may be determined by electronically sensing thephysiological state of the user and collecting the contextual data ofthe user. The physiological state may be sensed with a sensor of awearable device. Information from the sensing wearable and/orthird-party sources (e.g. social media) may be used to determine theuser's condition, and coordinate delivery of appropriate stimulationtherapy.

In an example, the sensor may determine HRV. In another example, thesensor may be an audio sensor that senses vocal data, such as a yawn, asigh, a yell, a vocal pitch, a vocal tone, a speaking speed, a vocalvolume, an acoustic characteristic, or the like. The contextual data maybe sensed or collected from a device separate from the wearable device(e.g. smartphone, fitness monitor, smart watch, smart speaker, smarteyewear, connected vehicle, smart headphones, etc.), a social mediaplatform, an environmental sensor, third party data, or the like. Forexample, social media posts may be analyzed to derive indicative of amood of the user (e.g. negative, positive, frustration, anger, anxiety,distracted, etc.). In another example of contextual data, the user'smovement or location data may be sensed or collected, such as from amobile device of the user. The system may determine if the user'slocation is indicative, or predictive, of the mood of the user. Othercontextual user data may include calendar entries, project managemententries, social media content, screen time, or a current sensed activity(e.g. flying, commuting, in traffic) to modify an aspect of thestimulation, trigger, or discontinue the stimulation. In embodiments,various metrics of user activity may be extrapolated from the contextualuser data, optionally in combination with other data, to obtain asignature of data associated with the user for when they feel that lifeis great (which may be a goal or target state for the user), when theyfeel poorly, or any state in between. This life signature, which may bea personalized goal state, may be monitored by the system to predictwhen the user's overall mood or feeling of well-being is beginning todecline, such as when their life signature begins to move away fromgreat and towards poor. Upon detecting a predicted or actual decline,the system may trigger stimulation that may be targeted at mitigatingfurther decline and/or supporting positive feelings. One such example ofa detectable pattern contributing to a declining life signature would bewhen consistently poor sleep is detected via wearable actigraphy.

A signature for various other personalized goal states may be developedusing sensed or collected data as described herein (e.g. physiological,contextual, environmental, etc.), such as a running goalstate/signature, a sleep goal state/signature, an at-work goalstate/signature, a performance state, a relaxed state, a focused state,or the like. In one method of establishing a personalized goal state,while receiving a first transcutaneous vibratory output to achieve adesired target state, the user may provide feedback on if they havereached the target state. A user interface may be used by the user toselect a target state or input the data regarding whether the user hasachieved the desired target state. If the user has achieved the desiredtarget state, at least one of contextual or biometric data of the usermay be obtained while the user is in the target state. Biometric datamay be obtained with an optionally wearable electronic sensor. Obtainingthe contextual data may include receiving data from third-partyapplications. The at least one of contextual or biometric data of theuser while the user is in the target state may be stored, such as in auser profile, as a baseline or personalized goal state. The personalizedgoal states may be stored in a user profile along with any otheradditional data, such as identifying data associated with the state andstimulation parameters. A particular stimulation pattern and parametersfor its delivery may be associated with maintaining or encouraging entryinto the personalized goal state. Continuing with the method, the user'scontextual and/or biometric data may be collected again, periodically,or continuously, and used to determine if the user is not in thebaseline state. If the user is determined to not be in the baselinestate, a transcutaneous vibratory output aimed at assisting the user toachieve the state is generated for application to a portion of theuser's body. Either of the first or second transcutaneous vibratoryoutput may be emitted with or through an electronic transducer.

When a predicted state is identified, delivery of a therapeuticstimulation pattern may be triggered, discontinued, modified, tapered,or ramped up. The system may generate or trigger a transcutaneousvibratory output to be applied to a portion of the user's body, such aswith a wearable device, to assist the user in at least one of addressingor avoiding the predicted state. As described herein, the transcutaneousvibratory output may have variable parameters comprising a perceivedpitch, a perceived beat, and a perceived intensity, wherein each of thevariable parameters can be dynamically modified based on, for example,the predicted emotional state, a physiological state or contextual data.In some embodiments, the transcutaneous vibratory output may havemultiple segments, wherein each segment may have at least one of aperceived pitch, a perceived beat, and a perceived intensity assigned toit, and wherein each of these variables may be different or the samebetween segments. Assigning the perceived pitch may be by at least oneof increasing or decreasing the perceived pitch. Assigning the perceivedbeat may be by at least one of increasing or decreasing the perceivedbeat.

Triggering may be sufficiently in advance of the actual onset of thepredicted state such that the stimulation results in avoidance of thepredicted state. In embodiments, when the estimated state is determined,a notification may be triggered to a user. The notification may includea suggestion that a therapeutic stimulation protocol be commenced,wherein the user may choose to manually commence the protocol. Aresponse to the stimulation (e.g. from sensors in wearable), movementdata, and/or a manual/behavioral response to the therapeutic stimulation(e.g. turning off the stimulation, increasing intensity, changingsettings) may be used as feedback to the system. The feedback may beused to identify a current physiological state of the user and may beused to dynamically modify the variable parameters. For example, any oneof the perceived pitch, a perceived beat, and a perceived intensity maybe modified based on the feedback during application of a firsttranscutaneous vibratory output, such as to cause a secondtranscutaneous vibratory output to be generated and applied.

In certain embodiments, the system may use any now or hereafter knownmachine learning algorithms to define new stimulation patterns and/orupdate existing stimulation patterns for a user based on collectedbiometric data, user's manual adjustment in response to stimulationapplied to the user (either for training the system and/or in realtime), or the like. In some embodiments, the system may utilize machinelearning with sensor data to predict an estimated state and may cause ortrigger an action in response to a new predicted state. Machine learningmay utilize training data from users that includes sensor data,including point, trend, and longitudinal data, associated with knownstates. An algorithm may use the training data to learn the correlationbetween the sensor data and the state and be able to predict what theuser's state is or that the state is imminent. For example, sensor data,for training, validation or use, may include any of the sensor datatypes described herein, including GSR, Heart Rate, HF-HRV, HRV interval,other HRV parameters (LF, IBI, Total power, LF/HF ratio, RMSSD, etc.),blood pressure, brain waves (EEG), facial recognition, vocal cues,mobile device usage data, facial recognition, and the like. Machinelearning may be used to learn a user's baseline state and predict thatthe state is changing or has changed, and in embodiments, what the newstate is, such as anxious, drowsy, awake, or the like. In embodiments,when the estimated state is predicted, a therapeutic stimulationprotocol may be triggered. Triggering may be sufficiently in advancesuch that the stimulation results in avoidance of the predicted state.In embodiments, when the estimated state is determined, a notificationmay be triggered to a user of the state. The notification may include asuggestion that a therapeutic stimulation protocol be commenced. Abiometric response to the therapeutic stimulation (e.g. from sensors inwearable), movement data, and/or a manual/behavioral response to thetherapeutic stimulation (e.g. turning off the stimulation, increasingintensity, changing settings) may also be used as seeds for machinelearning.

In an embodiment, delivery of stimulation described herein may bepaired, coordinated and/or synchronized with one or more other sensorystimuli 122, such as touch, visual stimulation/sight, sound, olfactorystimulation/smell, taste, electrical, or the like. For example, with astimulation device, a first transcutaneous vibratory output to beapplied to a portion of the user's body may be generated. In someembodiments, the sensory stimulation 122 may be applied with thestimulation device or may be in a separate device. The stimulationdevice may include both a transducer and a sensory output device. Inembodiments, a condition of the user may be assessed. Based on thecondition, one or more aspects of the stimulation and/or paired sensorystimuli may be selected or altered. In an embodiment, the sensorystimulation may be based on at least one of the assessed condition ofthe user or the selected beat output pattern.

In any of the aforementioned embodiments, the transcutaneous vibratoryoutput may be applied concomitantly with a treatment modality (e.g.psychotherapy, physical therapy, mindfulness activity), wherein thetreatment modality is based on the condition of the subject or a targetstate of the subject. In these embodiments, the transcutaneous vibratoryoutput may act synergistically with or augment the treatment modality toachieve a positive outcome or enhance engagement in the treatmentmodality. An application for guided mindfulness may include a facilityfor programming and/or initiating delivery of a stimulation therapy andguiding the user through a series of mindfulness prompts, such as guidedauditory sessions, during the delivery. The application may prompt theuser periodically regarding initiating a delivery of stimulation therapyas part of the guidance. The application user interface may visuallydepict biometric changes the user experiences during the guidance.

Medical treatments such as prescription drug therapy are widely used totreat various medical conditions and disorders. Many prescription drugsproduce side effects and adverse reactions in subjects, which can leadto considerable discomfort and poor quality of life. While such drugsmay attenuate a certain disorder, they may exacerbate other disorders.For example, side effects of various drugs may be sleep disorders, lossof appetite or other eating disorders, depression, stress, hypertension,digestive issues, pain, cognitive impairment, etc. Similarly, othermedical treatments (e.g., hospitalization, surgery, inpatientprocedures, psychotherapy) may also produce side effects such as stress,depression, sleep disorders, hypertension, etc.

At least some of these side effects may be caused due to an imbalancebetween the sympathetic and parasympathetic branches of the autonomicnervous system (ANS). As such, ways for monitoring the side effects of amedical treatment and mitigating the same by stimulating the sympatheticand/or the parasympathetic branches of the ANS are desired.

In one or more embodiments, the system 100 may be used to addressphysiological and/or psychological aspects of a subject's functioningthat may be attributed to a medical treatment (e.g., drug side effects,effects of psychotherapy, inpatient procedures, etc.). This may includedetermining what aspect of a subject's functioning have been affected bythe medical treatment being administered by collecting physiologicaldata from a subject using a sensor device, analyzing and comparing thephysiological data to a baseline state of the subject, and applyingvibrational energy to the subject at an appropriate frequency,intensity, duration, etc.

In one or more embodiments and referring to FIG. 15, the baseline stateof a subject may correspond to the state of a subject prior to the startof a medical treatment (e.g., before drug therapy is started, beforehospitalization, etc.), and may include physiological data(corresponding to measurable physiological attributes) collected fromthe subject before start of the medical treatment 1502. Suchphysiological data may include, for example and without limitation,heart rate, blood metabolite concentrations, respiration rate, bloodpressure, or other quantifiable data that may have a correlation withthe potential side effects of the medical treatment. For example, someindications of stress include higher resting pulse rate, frequent sharpspikes in heart rate; shallow respirations, decreased movement for athreshold period of time; high blood pressure; high heart rate with lowheart rate variability (in the absence of physical activity); suddenintense increases in sweating (in the absence of physical activity), orcombinations thereof. Therefore, if the potential side effect of amedical treatment is stress, the baseline state may includephysiological data such as resting pulse rate, heart rate, rate ofrespiration, blood pressure, etc. Medical treatment may commence 1504and the system may continuously and/or periodically collectphysiological data 1508 from the subject upon start of the medicaltreatment and analyze it to determine if one or more of the aboveindications for stress are present 1510. If one or more data collectedby the sensor device correlate to conditions of stress, vibrationalenergy at a beat frequency for alleviation of stress may be applied 1512to the subject.

Alternatively, and/or additionally, some side effects may be acceptableduring a medical treatment and/or the baseline may be different (that isthey may be acceptable up to a certain level), and a user or a medicalpractitioner may define the baseline state accordingly.

A subject may be monitored to identify potential side effects orunwanted effects of a medical treatment during the administration of themedical treatment and/or for a predetermined time after completion themedical treatment. The indications of a side effect may be differentand/or the baseline may be different during a medical treatment comparedto those upon completion of a medical treatment.

In embodiments, delivery of stimulation described herein may beadministered with a compound, such as a pharmaceutical compound, apsychoactive compound (e.g. MDMA), a psychedelic (e.g. psilocybin), ananti-depressant, an anti-anxiety drug, an amphetamine, a medicament, atherapeutic agent, cannabis, or the like. In some embodiments, thestimulation may mitigate the negative side effects of the compounds,such as by attenuating the restlessness or anxiety associated with thecompound and/or the therapeutic experience. In this embodiment, thestimulation device or an associated device may interpret changes in aparameter of a user's state, which may be attributable to the compound,and then apply a stimulation that enhances or augments the benefit ofthe compound by mitigating its negative side effects and/or synergizingwith or augmenting the beneficial or positive effects of the compound.In some embodiments, the administration of the compound and thestimulation may be done in a controlled session, such as a psychotherapysession. Mitigating the side effects of certain drugs, such as therestlessness that often accompanies many psychoactive drugs, may enhancetheir use in the psychotherapeutic treatment of certain disorders, suchas PTSD or depression, and may enable patients to engage moreeffectively in therapy.

In practice, a drug or other compound may be administered to a subjectin a therapy session, wherein the drug is one of a psychoactive compound(e.g. MDMA, psilocybin), a psychoactive compound, a psychedelic, atherapeutic agent, cannabis, or some other herbal or pharmaceuticalcompound or therapeutic agent. The subject may be monitored to determineif the effects of the drug are counterproductive to the therapy session(e.g. anxiety, restlessness). Monitoring may be done using sensors togenerate biometric data of the subject, or may be done by anotherparticipant in the therapy session. Sensors may be part of a stimulationdevice or may be part of another device or environmental. For example, asensor may be used to determine HRV, which may be associated withanxiety. In another example, the sensor may be an audio sensor thatsenses vocal data such as a yell, a cry, an increased vocal tone, or thelike.

Once determined that the drug is having a negative side effect, thestimulation device may be triggered to provide tactile stimulation tothe subject during the therapy session, wherein the transcutaneousvibratory output and/or any of the underlying variable parameters areselected 1514 to reduce the undesirable or unwanted effects of the drug,and in some embodiments, may be based on the kind of effects beingexperienced. In the case where another participant is monitoring thesubject for negative side effects, the stimulation device may bemanually triggered to choose and/or deliver a transcutaneous vibratoryoutput. The transcutaneous vibratory output may be a combination ofoscillations as described herein (e.g. a perceived pitch or a mainoscillation at a first frequency and a perceived beat or a modulationoscillation at a second frequency that together form a beat output; aselected envelope bounded by a base tone; a perceived pitch and aperceived beat). In an embodiment, the beat and/or pitch may be selectedbased on the effects of the drug. In an embodiment, the perceived pitchand/or perceived beat may be altered based on the effects of the drug.

In addition to applying a stimulation to mitigate the negative sideeffects of certain drugs, a sensory stimulation may also be applied tothe subject. The sensory stimulation may be one or more of a visualstimulation, an olfactory stimulation, a taste stimulation, a touch, ora sound, and may be selected based on the effects of the drug. Further,treatment may be coordinated with one or more other devices fortreatment or measurement (e.g. blood pressure cuff, pulse ox, auralstim, light stim, music).

In this embodiment, and in any of the embodiments disclosed herein, theparameters of the applied transcutaneous vibrational energy (e.g.,frequency, intensity, duration, etc.) may be determined based on thephysiological data collected by the sensor device 118. Typically, fastand high intensity vibrations may cause an increase in heart rate,respirations, blood pressure, and sweat while decreasing heart ratevariability. On the other hand, slow, gentle, low intensity vibrationsmay cause a decrease in heart rate, respirations, blood pressure, andsweat while increasing heart rate variability.

Furthermore, the parameter values and examples in this disclosure areprovided for example purposes only and may be adjusted or tuned for asubject based on the subject's physiological reactions and data using afeedback loop, as described herein. Specifically, the parameters may bepersonalized to a subject based on physiological data collected by thesensor device 118 (e.g., heart rate, heart rate variability, bloodpressure, respirations, sweat level, resting pulse rate, brain activity,etc.) and/or based on user feedback. Specifically, in variousembodiments, data collected by the sensor device 118 may be used in afeedback loop to initiate and/or control the application of stimulus tothe subject, via the stimulation device 102. Additionally, and/oralternatively, the data collected by the sensor device to select andpersonalize the application of stimulation to the subject 114 may bebased on the data collected by the sensor device 118. For example, thefrequency ranges, stimulation patterns, stimulation application times,stimulation application duration, or the like may be personalized to auser.

Furthermore, the underlying frequencies of the stimulation may beadjusted based on a subject's response to the application of the beatfrequency in a real-time manner. For example, if the data collected bythe sensor device 118 indicates that an initial stimulation did notalleviate the stress symptoms (e.g., the resting pulse rate did notdecrease to a non-stress level), the applied frequencies may begradually increased until the desired effect is achieved. Alternatively,and/or additionally, if the data collected by the sensor device 118indicates that the stimulation is reducing stress in a subject (e.g.,the resting pulse rate slowly decreasing), the applied frequencies maybe gradually tapered to a shutdown level.

In addition to the beat frequency being controlled in real-time based ondata collected by the sensor device 118, user feedback may also be usedto control the application of the stimulation (e.g., turning off,turning up intensity, changing settings, etc.)

In certain embodiments, the baseline state of a subject may alsocorrespond to the state of an average person with similar physicalattributes as the subject undergoing medical treatment (e.g., samegender, weight, height, BMI, etc.). For example, some indications ofstress include, without limitation, a resting pulse of about 60 beatsper minute (bpm) for a healthy man and greater than about 70 bpm for ahealthy woman; frequent sharp spikes in heart rate; shallow respirationsat a rate of greater than about 12 breaths/minute; decreased movementfor a threshold period of time; blood pressure greater than 120/80 mm ofHg in a healthy male (in the absence of physical activity); high heartrate with low heart rate variability (in the absence of physicalactivity); sudden intense increases in sweating (in the absence ofphysical activity); or combinations thereof.

In embodiments, external or secondary devices and services may becontrolled based on current state or goal state achievement, such asdetermined by a sensor, external data source, or user input. Controllingthe operation of third-party devices may be based on the predicted oractual state achieved based on the delivery of stimulation therapy. Forexample, when a user has reached a state, the stimulation device may betriggered to deliver a stimulation pattern and/or make an environmentaladjustment, such as to turn off/on lights, change light color, changeroom temperature, commence/discontinue aromatherapy, lower/raise windowshades, turn on/off music, trigger a secondary stimulating device in amattress/pillow, etc.). In another embodiment, when the user reaches astate upon having applied stimulation (e.g. more alert), a vibrating carmassage seat may be triggered. In another embodiment, when a user hasreached a state of emergence from a nap, a red light may be illuminatedwith increased frequency to aid with exiting the nap. In anotherembodiment, when a user has reached a state, at least one of a contentdelivery setting or a content filter for applications and communicationsmay be adjusted. The content filter may determine the types of contentdelivered to the user. The setting may be a do not disturb setting. Inanother embodiment, when a user has reached a state, a social mediasetting may be adjusted, such as a do not disturb setting or a contentdelivery setting. In another embodiment, when a user has reached astate, they may be prompted to perform a certain a task. In any of theaforementioned examples, controlling operations and services may resultfrom the stimulation device or associated sensor or processortransmitting an instruction or trigger to another device/server orsystem controller. Alternatively, the other device or server mayperiodically check the stimulation device, associated sensor/processor,or remote location aggregating data from the same and determine if atriggering event or data point has occurred. In embodiments, thestimulation device may transmit data to a remote server or cloudlocation that can be accessed by third party devices or controllers totrigger actions.

In embodiments, the system may control the operation of third-partydevices to achieve a state based on the delivery of stimulation therapy.For example, when a calming transcutaneous vibratory output commences,the system may instruct dimming of lights in the vicinity. Conversely,if a waking therapy begins, instructions may be sent to brighten lightsand lift window blinds.

In an embodiment, another solution described herein is how to cause andtrack epigenetic changes as a result of employing the methods anddevices described herein. There is growing evidence that epigeneticregulation of gene expression is related to trauma exposure, may beinvolved in the pathophysiology and treatment response in PTSD patients,and modifications in epigenetic regulation and the epigenome may bepersistent and potentially inheritable by subsequent generations. Someof this evidence relates to methylation and acetylation patterns ofcertain genes, which is associated with regulating expression levels ofthe different portions of these genes, which are ultimately transcribedand translated into proteins. In some embodiments and referring to FIG.16, applying a therapeutic stimulation to achieve a target state 1604(e.g. mental presence, flow, optimal performance, relaxation,non-depressed, etc.) in accordance with this disclosure and either for asingle time, intermittently, or repeatedly over a period of time, mayresult in the causation of or the priming for a measurable epigeneticchange in the incidence of: a psychological state-, illness-, disorder-,trauma-, or stress-related regulation of certain proteins (e.g. stresshormones, receptors, receptor ligands, growth factors, and the like), amethylation/acetylation/phosphorylation pattern of a gene or histone, orthe incidence of regulation of a reward response gene or protein (e.g.neurotransmitter, neurotransmitter receptors, ion channels, and thelike), wherein regulation can be any of increasing levels, decreasinglevels, silencing, and the like. Epigenetic markers may be measuredbefore 1602 and after 1608 transcutaneous vibratory stimulation in orderto assess the epigenetic impact of the stimulation. The causation or thepriming for epigenetic changes may be a result of the therapeuticstimulation itself, the achievement of the target state and theassociated physical manifestations of the target state (e.g. achievementof a resonant frequency or resonant state, improved balance between theparasympathetic and sympathetic nervous system, increases in HRV, etc.),a mechanosensitive change in a receptor or receptor affinity, adownstream effect of a mechanosensitive change in a receptor or receptoraffinity, or some combination thereof. In the absence of measuringepigenetic changes directly as described herein (e.g. measuring themethylation or acetylation profile of certain genes pre- andpost-treatment, measuring the levels of expression of reward responseproteins or stress-related proteins, etc.), certain proxy measurementsmay be useful in extrapolating an epigenetic change. One proxy may bestress indicators in communications, such as social media posts, mobiledevice usage, texts, calls, or the like, such as the presence, absence,or frequency of positive or negative words used, or vocaltone/pitch/vocal rate related to the life signature. Another proxy maybe a faster time to reach a target state after continued use. Anotherproxy may be a longer dwell in the target state. In embodiments,stimulation therapy targeted at causing an epigenetic change may beco-delivered with a sensory stimuli, physical therapy/massage, and/or apharmaceutical treatment.

While only a few embodiments of the present disclosure have been shownand described, it will be obvious to those skilled in the art that manychanges and modifications may be made thereunto without departing fromthe spirit and scope of the present disclosure as described in thefollowing claims. All patent applications and patents, both foreign anddomestic, and all other publications referenced herein are incorporatedherein in their entireties to the full extent permitted by law.

The methods and systems described herein may be deployed in part or inwhole through a machine that executes computer software, program codes,and/or instructions on a processor. The present disclosure may beimplemented as a method on the machine, as a system or apparatus as partof or in relation to the machine, or as a computer program productembodied in a computer readable medium executing on one or more of themachines. In embodiments, the processor may be part of a server, cloudserver, client, network infrastructure, mobile computing platform,stationary computing platform, or other computing platform. A processormay be any kind of computational or processing device capable ofexecuting program instructions, codes, binary instructions, and thelike. The processor may be or may include a signal processor, digitalprocessor, embedded processor, microprocessor, or any variant such as aco-processor (math co-processor, graphic co-processor, communicationco-processor, and the like) and the like that may directly or indirectlyfacilitate execution of program code or program instructions storedthereon. In addition, the processor may enable execution of multipleprograms, threads, and codes. The threads may be executed simultaneouslyto enhance the performance of the processor and to facilitatesimultaneous operations of the application. By way of implementation,methods, program codes, program instructions, and the like describedherein may be implemented in one or more thread. The thread may spawnother threads that may have assigned priorities associated with them;the processor may execute these threads based on priority or any otherorder based on instructions provided in the program code. The processor,or any machine utilizing one, may include non-transitory memory thatstores methods, codes, instructions, and programs as described hereinand elsewhere. The processor may access a non-transitory storage mediumthrough an interface that may store methods, codes, and instructions asdescribed herein and elsewhere. The storage medium associated with theprocessor for storing methods, programs, codes, program instructions, orother type of instructions capable of being executed by the computing orprocessing device may include but may not be limited to one or more of aCD-ROM, DVD, memory, hard disk, flash drive, RAM, ROM, cache, and thelike.

A processor may include one or more cores that may enhance speed andperformance of a multiprocessor. In embodiments, the process may be adual core processor, quad core processors, other chip-levelmultiprocessor and the like that combine two or more independent cores(called a die).

The methods and systems described herein may be deployed in part or inwhole through a machine that executes computer software on a server,client, firewall, gateway, hub, router, or other such computer and/ornetworking hardware. The software program may be associated with aserver that may include a file server, print server, domain server,internet server, intranet server, cloud server, and other variants suchas secondary server, host server, distributed server, and the like. Theserver may include one or more of memories, processors, computerreadable transitory and/or non-transitory media, storage media, ports(physical and virtual), communication devices, and interfaces capable ofaccessing other servers, clients, machines, and devices through a wiredor a wireless medium, and the like. The methods, programs, or codes asdescribed herein and elsewhere may be executed by the server. Inaddition, other devices required for execution of methods as describedin this application may be considered as a part of the infrastructureassociated with the server.

The server may provide an interface to other devices including, withoutlimitation, clients, other servers, printers, database servers, printservers, file servers, communication servers, distributed servers,social networks, and the like. Additionally, this coupling and/orconnection may facilitate remote execution of program across thenetwork. The networking of some or all of these devices may facilitateparallel processing of a program or method at one or more locationswithout deviating from the scope of the disclosure. In addition, any ofthe devices attached to the server through an interface may include atleast one storage medium capable of storing methods, programs, code,and/or instructions. A central repository may provide programinstructions to be executed on different devices. In thisimplementation, the remote repository may act as a storage medium forprogram code, instructions, and programs.

The software program may be associated with a client that may include afile client, print client, domain client, internet client, intranetclient, and other variants such as secondary client, host client,distributed client, and the like. The client may include one or more ofmemories, processors, computer readable transitory and/or non-transitorymedia, storage media, ports (physical and virtual), communicationdevices, and interfaces capable of accessing other clients, servers,machines, and devices through a wired or a wireless medium, and thelike. The methods, programs, or codes as described herein and elsewheremay be executed by the client. In addition, other devices required forexecution of methods as described in this application may be consideredas a part of the infrastructure associated with the client.

The client may provide an interface to other devices including, withoutlimitation, servers, other clients, printers, database servers, printservers, file servers, communication servers, distributed servers, andthe like. Additionally, this coupling and/or connection may facilitateremote execution of a program across the network. The networking of someor all of these devices may facilitate parallel processing of a programor method at one or more location without deviating from the scope ofthe disclosure. In addition, any of the devices attached to the clientthrough an interface may include at least one storage medium capable ofstoring methods, programs, applications, code, and/or instructions. Acentral repository may provide program instructions to be executed ondifferent devices. In this implementation, the remote repository may actas a storage medium for program code, instructions, and programs.

In embodiments, one or more of the controllers, circuits, systems, datacollectors, storage systems, network elements, or the like as describedthroughout this disclosure may be embodied in or on an integratedcircuit, such as an analog, digital, or mixed signal circuit, such as amicroprocessor, a programmable logic controller, an application-specificintegrated circuit, a field programmable gate array, or other circuit,such as embodied on one or more chips disposed on one or more circuitboards, such as to provide in hardware (with potentially acceleratedspeed, energy performance, input-output performance, or the like) one ormore of the functions described herein. This may include setting upcircuits with up to billions of logic gates, flip-flops, multiplexers,and other circuits in a small space, facilitating high speed processing,low power dissipation, and reduced manufacturing cost compared withboard-level integration. In embodiments, a digital IC, typically amicroprocessor, digital signal processor, microcontroller, or the likemay use Boolean algebra to process digital signals to embody complexlogic, such as involved in the circuits, controllers, and other systemsdescribed herein. In embodiments, a data collector, an expert system, astorage system, or the like may be embodied as a digital integratedcircuit (“IC”), such as a logic IC, memory chip, interface IC (e.g., alevel shifter, a serializer, a deserializer, and the like), a powermanagement IC and/or a programmable device; an analog integratedcircuit, such as a linear IC, RF IC, or the like, or a mixed signal IC,such as a data acquisition IC (including A/D converters, D/A converter,digital potentiometers) and/or a clock/timing IC.

The methods and systems described herein may be deployed in part or inwhole through network infrastructures. The network infrastructure mayinclude elements such as computing devices, servers, routers, hubs,firewalls, clients, personal computers, communication devices, routingdevices and other active and passive devices, modules and/or componentsas known in the art. The computing and/or non-computing device(s)associated with the network infrastructure may include, apart from othercomponents, a storage medium such as flash memory, buffer, stack, RAM,ROM, and the like. The processes, methods, program codes, instructionsdescribed herein and elsewhere may be executed by one or more of thenetwork infrastructural elements. The methods and systems describedherein may be configured for use with any kind of private, community, orhybrid cloud computing network or cloud computing environment, includingthose which involve features of software as a service (“SaaS”), platformas a service (“PaaS”), and/or infrastructure as a service (“IaaS”).

The methods, program codes, and instructions described herein andelsewhere may be implemented on a cellular network having multiplecells. The cellular network may either be frequency division multipleaccess (“FDMA”) network or code division multiple access (“CDMA”)network. The cellular network may include mobile devices, cell sites,base stations, repeaters, antennas, towers, and the like. The cellnetwork may be a GSM, GPRS, 3G, EVDO, mesh, or other networks types.

The methods, program codes, and instructions described herein andelsewhere may be implemented on or through mobile devices. The mobiledevices may include navigation devices, cell phones, mobile phones,mobile personal digital assistants, laptops, palmtops, netbooks, pagers,electronic books readers, music players and the like. These devices mayinclude, apart from other components, a storage medium such as a flashmemory, buffer, RAM, ROM and one or more computing devices. Thecomputing devices associated with mobile devices may be enabled toexecute program codes, methods, and instructions stored thereon.Alternatively, the mobile devices may be configured to executeinstructions in collaboration with other devices. The mobile devices maycommunicate with base stations interfaced with servers and configured toexecute program codes. The mobile devices may communicate on apeer-to-peer network, mesh network, or other communications network. Theprogram code may be stored on the storage medium associated with theserver and executed by a computing device embedded within the server.The base station may include a computing device and a storage medium.The storage device may store program codes and instructions executed bythe computing devices associated with the base station.

The computer software, program codes, and/or instructions may be storedand/or accessed on machine readable transitory and/or non-transitorymedia that may include: computer components, devices, and recordingmedia that retain digital data used for computing for some interval oftime; semiconductor storage known as random access memory (“RAM”); massstorage typically for more permanent storage, such as optical discs,forms of magnetic storage like hard disks, tapes, drums, cards and othertypes; processor registers, cache memory, volatile memory, non-volatilememory; optical storage such as CD, DVD; removable media such as flashmemory (e.g., USB sticks or keys), floppy disks, magnetic tape, papertape, punch cards, standalone RAM disks, zip drives, removable massstorage, off-line, and the like; other computer memory such as dynamicmemory, static memory, read/write storage, mutable storage, read only,random access, sequential access, location addressable, fileaddressable, content addressable, network attached storage, storage areanetwork, bar codes, magnetic ink, and the like.

The methods and systems described herein may transform physical and/oror intangible items from one state to another. The methods and systemsdescribed herein may also transform data representing physical and/orintangible items from one state to another.

The elements described and depicted herein, including in flow charts andblock diagrams throughout the Figures, imply logical boundaries betweenthe elements. However, according to software or hardware engineeringpractices, the depicted elements and the functions thereof may beimplemented on machines through computer executable transitory and/ornon-transitory media having a processor capable of executing programinstructions stored thereon as a monolithic software structure, asstandalone software modules, or as modules that employ externalroutines, code, services, and so forth, or any combination of these, andall such implementations may be within the scope of the presentdisclosure. Examples of such machines may include, but may not belimited to, personal digital assistants, laptops, personal computers,mobile phones, other handheld computing devices, medical equipment,wired or wireless communication devices, transducers, chips,calculators, satellites, tablet PCs, electronic books, gadgets,electronic devices, devices having artificial intelligence, computingdevices, networking equipment, servers, routers, and the like.Furthermore, the elements depicted in the flow chart and block diagramsor any other logical component may be implemented on a machine capableof executing program instructions. Thus, while the foregoing drawingsand descriptions set forth functional aspects of the disclosed systems,no particular arrangement of software for implementing these functionalaspects should be inferred from these descriptions unless explicitlystated or otherwise clear from the context. Similarly, it will beappreciated that the various steps identified and described above may bevaried, and that the order of steps may be adapted to particularapplications of the techniques disclosed herein. All such variations andmodifications are intended to fall within the scope of this disclosure.As such, the depiction and/or description of an order for various stepsshould not be understood to require a particular order of execution forthose steps, unless required by a particular application, or explicitlystated or otherwise clear from the context.

The methods and/or processes described above, and steps associatedtherewith, may be realized in hardware, software or any combination ofhardware and software suitable for a particular application. Thehardware may include a general-purpose computer and/or dedicatedcomputing device or specific computing device or particular aspect orcomponent of a specific computing device. The processes may be realizedin one or more microprocessors, microcontrollers, embeddedmicrocontrollers, programmable digital signal processors or otherprogrammable device, along with internal and/or external memory. Theprocesses may also, or instead, be embodied in an application specificintegrated circuit, a programmable gate array, programmable array logic,or any other device or combination of devices that may be configured toprocess electronic signals. It will further be appreciated that one ormore of the processes may be realized as a computer executable codecapable of being executed on a machine-readable medium.

The computer executable code may be created using a structuredprogramming language such as C, an object oriented programming languagesuch as C++, or any other high-level or low-level programming language(including assembly languages, hardware description languages, anddatabase programming languages and technologies) that may be stored,compiled or interpreted to run on one of the above devices, as well asheterogeneous combinations of processors, processor architectures, orcombinations of different hardware and software, or any other machinecapable of executing program instructions.

Thus, in one aspect, methods described above and combinations thereofmay be embodied in computer executable code that, when executing on oneor more computing devices, performs the steps thereof. In anotheraspect, the methods may be embodied in systems that perform the stepsthereof, and may be distributed across devices in a number of ways, orall of the functionality may be integrated into a dedicated, standalonedevice or other hardware. In another aspect, the means for performingthe steps associated with the processes described above may include anyof the hardware and/or software described above. All such permutationsand combinations are intended to fall within the scope of the presentdisclosure.

While the disclosure has been disclosed in connection with the preferredembodiments shown and described in detail, various modifications andimprovements thereon will become readily apparent to those skilled inthe art. Accordingly, the spirit and scope of the present disclosure isnot to be limited by the foregoing examples, but is to be understood inthe broadest sense allowable by law.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the disclosure (especially in the context of thefollowing claims) is to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. Recitation of ranges of valuesherein are merely intended to serve as a shorthand method of referringindividually to each separate value falling within the range, unlessotherwise indicated herein, and each separate value is incorporated intothe specification as if it were individually recited herein. All methodsdescribed herein can be performed in any suitable order unless otherwiseindicated herein or otherwise clearly contradicted by context. The useof any and all examples, or exemplary language (e.g., “such as”)provided herein, is intended merely to better illuminate the disclosure,and does not pose a limitation on the scope of the disclosure unlessotherwise claimed. No language in the specification should be construedas indicating any non-claimed element as essential to the practice ofthe disclosure.

While the foregoing written description enables one skilled in the artto make and use what is considered presently to be the best modethereof, those skilled in the art will understand and appreciate theexistence of variations, combinations, and equivalents of the specificembodiment, method, and examples herein. The disclosure should thereforenot be limited by the above described embodiment, method, and examples,but by all embodiments and methods within the scope and spirit of thedisclosure.

Any element in a claim that does not explicitly state “means for”performing a specified function, or “step for” performing a specifiedfunction, is not to be interpreted as a “means” or “step” clause asspecified in 35 U.S.C. § 112(f). In particular, any use of “step of” inthe claims is not intended to invoke the provision of 35 U.S.C. §112(f).

Persons skilled in the art may appreciate that numerous designconfigurations may be possible to enjoy the functional benefits of theinventive systems. Thus, given the wide variety of configurations andarrangements of embodiments of the present invention, the scope of theinvention is reflected by the breadth of the claims below rather thannarrowed by the embodiments described above.

What is claimed is:
 1. A method to mitigate negative effects of a drugin a treatment of a mental health condition, the method comprising:administering the drug to a subject in a controlled therapy session;determining effects of the drug, the effects being counterproductive tothe controlled therapy session; and providing tactile stimulation to thesubject with a stimulation device that generates transcutaneousvibratory output to be applied to a portion of a body of the subjectduring the controlled therapy session, wherein the transcutaneousvibratory output is generated by a combination of oscillations, thecombination of oscillations comprising a first oscillation at a firstfrequency and a second oscillation at a second frequency that togetherform an output with a first predetermined beat pattern, wherein thefirst predetermined beat pattern is selected to reduce thecounterproductive effects of the drug, wherein the first predeterminedbeat pattern, in response to the effects being counterproductive, isadjusted from the first predetermined beat pattern to a secondpredetermined beat pattern over a time period in the controlled therapysession by adjusting at least one of the first frequency or the secondfrequency over the time period, and wherein the second predeterminedbeat pattern is selected to reduce the counterproductive effects of thedrug.
 2. The method of claim 1, wherein determining the effects of thedrug further comprises utilizing sensors to generate biometric data ofthe subject.
 3. The method of claim 2, wherein the counterproductiveeffects of the drug comprise at least one of anxiety or restlessness. 4.The method of claim 1, further comprising selecting the transcutaneousvibratory output based on the effects of the drug.
 5. The method ofclaim 1, further comprising applying a sensory stimulation to thesubject.
 6. The method of claim 5, further comprising selecting thesensory stimulation based on the effects of the drug.
 7. The method ofclaim 6, wherein the sensory stimulation comprises visual stimulation.8. The method of claim 6, wherein the sensory stimulation comprisesolfactory stimulation.
 9. The method of claim 6, wherein the sensorystimulation comprises taste stimulation.
 10. The method of claim 1,wherein the drug is selected from the group consisting of MDMA,psilocybin, cannabis, an anti-depressant, an anti-anxiety drug, ananti-psychotic, and a psychoactive drug.
 11. The method of claim 1,further comprising, multiplicatively combining a sine wave-shapedenvelope generated using a perceived beat with a wave pattern generatedusing a perceived pitch to produce the transcutaneous vibratory output.12. The method of claim 11, wherein multiplicatively combining is inaccordance with the relationship:[sin(2.0*π*freq_perceived_pitch*t)]*[sin(π*freq_perceived_beat*t)]. 13.The method of claim 1, wherein the second frequency differs from thefirst frequency by less than 10 Hz.
 14. The method of claim 1, whereinan absolute value of a difference of the first frequency and the secondfrequency is less than 10 Hz.
 15. The method of claim 1, furthercomprising adjusting an intensity of the second pattern to maintain asame subjective intensity as the first pattern.
 16. The method of claim1, further comprising adjusting an intensity of the second pattern as afunction of the frequency of the second pattern.
 17. A method tomitigate negative effects of a drug in a treatment of a mental healthcondition, the method comprising: administering the drug to a subject ina controlled therapy session; determining effects of the drug, theeffects being counterproductive to the controlled therapy session;providing tactile stimulation to the subject with a stimulation devicethat generates transcutaneous vibratory output having a selectedenvelope and a selected base tone to be applied to a portion of a bodyof the subject during the controlled therapy session; and wherein thetranscutaneous vibratory output is selected to reduce thecounterproductive effects of the drug, and wherein the transcutaneousvibratory output has a first predetermined beat pattern and the firstpredetermined beat pattern, in response to the effects beingcounterproductive, is adjusted to a second predetermined beat patternover a time period in the controlled therapy session.
 18. The method ofclaim 17, further comprising selecting the selected envelope based onthe effects of the drug.
 19. The method of claim 17, further comprisingselecting the selected base tone based on the effects of the drug. 20.The method of claim 17, wherein determining the effects of the drugfurther comprises utilizing sensors to generate biometric data of thesubject.
 21. The method of claim 17, wherein the counterproductiveeffects of the drug comprise at least one of anxiety or restlessness.22. The method of claim 17, wherein the drug is selected from the groupconsisting of MDMA, psilocybin, cannabis, an anti-depressant, ananti-anxiety drug, an anti-psychotic, and a psychoactive drug.
 23. Themethod of claim 17, further comprising, multiplicatively combining theselected envelope generated using a perceived beat with the selectedbase tone generated using a perceived pitch to produce thetranscutaneous vibratory output.
 24. The method of claim 23, whereinmultiplicatively combining is in accordance with the relationship:[sin(2.0*π*freq_perceived_pitch*t)]*[sin(π*freq_perceived_beat*t)]. 25.The method of claim 17, wherein the selected base tone is at a firstfrequency, and the selected envelope is at a second frequency thatdiffers from the first frequency by less than 10 Hz.
 26. A method oftreating a subject comprising: administering a drug during a controlledtherapy session; determining effects of the drug on the subject in thecontrolled therapy session, the effects being counterproductive to thecontrolled therapy session; with a simulation device, applying to aportion of a body of the subject a transcutaneous vibratory outputhaving a perceived pitch and a perceived beat; and selectively alteringthe perceived pitch and the perceived beat to counteractcounterproductive effects of the drug, wherein at least one of theperceived pitch or the perceived beat are adjusted from a firstfrequency to a second frequency over a time period in the controlledtherapy session.
 27. The method of claim 26, wherein determining theeffects of the drug further comprises utilizing sensors to generatebiometric data of the subject.
 28. The method of claim 26, wherein thedrug is selected from the group consisting of MDMA, psilocybin,cannabis, an anti-depressant, an anti-anxiety drug, an anti-psychotic,and a psychoactive drug.
 29. The method of claim 26, wherein thecounterproductive effects of the drug comprise at least one of anxietyor restlessness.
 30. The method of claim 26, further comprising,multiplicatively combining a sine wave-shaped envelope generated usingthe perceived beat with a wave pattern generated using the perceivedpitch to produce the transcutaneous vibratory output.
 31. The method ofclaim 30, wherein multiplicatively combining is in accordance with therelationship:[sin(2.0*π*freq_perceived_pitch*t)]*[sin(π*freq_perceived_beat*t)]. 32.The method of claim 26, wherein the transcutaneous vibratory output isgenerated in part by a first oscillation, and a second oscillation,wherein the difference between the frequencies of the first oscillationand the second oscillation is less than 10 Hz.